2020-06-10 21:38
There's a new, AI-powered diabetes app that claims to accurately predict blood glucose levels sooner than the industry-leading continuous glucose monitoring (CGM) systems, which… Read More
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The experts on equipment manufacturers of medical devices and in vitro diagnostic products. MD+DIÂ helps industry professionals develop, design, and manufacture medical products that comply with complex and demanding regulations and market requirements.
2020-06-10 20:57
M&A is still a thing during the COVID-19 Pandemic. Advanced stroke imaging firm, RapidAI is acquiring EndoVantage, developer of the Find, Track, and Treat comprehensive cerebral aneurys… Read More
2020-06-10 20:38
The Department of Defense is funding a clinical trial of a COVID-19 treatment using ExThera Medical’s Seraph 100 Blood filter.
The device was selected to be in the multi-c… Read More
2020-06-08 19:50
A new study is shining more light on the importance of the vagus nerve - the focal point of bioelectronic therapy.
The study was led by Stavros Zanos, MD, Phd, assistant professor at the Fe… Read More
2020-06-08 19:42
Up until now, medical devices have been in the background when it comes to the novel coronavirus. The bigger stories in the industry came from diagnostic firms either developing virus detec… Read More
2020-06-08 18:59
From a revenue perspective, the biggest hit on the medical device industry during the height of the global coronavirus pandemic was the fact that most non-emergency procedures w… Read More
2020-06-05 20:09
Medtronic has scored CE mark for a unique indication for the Resolute Onyx drug-eluting stent. The Dublin-based company said the approval was for a DAPT indication for high bleeding risk (H… Read More
2020-06-05 16:09
Fitbit Dives Deeper Into Medtech with Ventilator
FDA granted an emergency use authorization for the Fitbit Flow, a low-cost ventilator, for use during the COVID-19 pandemic. The company sai… Read More
2020-06-05 15:27
Abiomed said it has received approval for an IDE to start an early feasibility study of what it is calling the “world’s smallest heart pump… Read More
2020-06-04 20:06
2020-06-04 19:48
Fitbit is continuing its rapid trajectory into the medtech industry with a new Emergency Use Authorization from FDA. The San Francisco, CA-based company said the EUA is for a low-cost emerg… Read More
2020-06-04 18:02
During the COVID-19 pandemic, medical device and diagnostics companies and their partners have been responding with rapid solutions to meet urgent healthcare needs. Much has been learned fr… Read More
2020-06-04 17:35
As a journalist covering the medical device industry for more than a decade, I cannot recall the last time AdvaMed took a stand on a controversial social or political issue. The trade assoc… Read More
2020-06-03 21:14
In more than 30% of dental implant cases, existing bone graft materials fail to achieve the desired clinical results, and another bone graft procedure must be conducted, increasing the over… Read More
2020-06-03 19:57
Bigfoot Biomedical hasn't let the coronavirus pandemic stand in the way of bringing its injection-based digitized insulin dosing platform to the U.S. market. If anything, CEO Je… Read More
2020-06-03 19:12
Fractyl Laboratories is seeking to ‘turn back the clock’ in Type 2 diabetes progression with its disease-modifying therapy.
FDA granted the Lexington, MA… Read More
2020-06-03 18:14
Medical device development consists of deliberate market strategy, exhaustive plans, iterative test cycles, and methodical documentation. So how should we respond to an unplanned emergency… Read More
2020-06-02 20:17
There has been no shortage of innovation and collaboration across the industry to provide critical medical solutions in response to the coronavirus pandemic, but developing a much-needed de… Read More
2020-06-02 17:59
Traditionally, dentists (and other medical professionals, for that matter) didn't have to worry about a social media presence. Times have changed, however, and a recent DentaVox… Read More
2020-06-02 16:23
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasi… Read More
2020-06-01 20:12
Sometimes when the discussion of tackling the novel coronavirus comes up, the use of medical devices gets lost in the shuffle. Most of the conversation surrounding COVID-19 comes from eithe… Read More
2020-06-01 18:57
The number of antibody tests for COVID-19 issued emergency use authorization continues to swell. Siemens Healthineers adds to that numbers as it said it has been issued EUA from FDA for an… Read More
2020-06-01 18:01
In the wake of widely reported shortfalls and unexplained re-routing of material in the Strategic National Stockpile (SNS) throughout the most critical stages of the COVID-19 pandemic, Cong… Read More
2020-05-29 18:55
Philips Wins Regulatory Nod for Clinical Surveillance Biosensor
Philips won a nod from FDA and a CE mark for a next-generation wireless wearable biosensor to help monitor COVID-19 patients… Read More
2020-05-29 18:18
Quest Diagnostics has won emergency use authorization for a self-collection kit for COVID-19. The Secaucus, NJ-based company said its test is for individuals to self-collect a nasal specime… Read More
2020-05-29 17:26
Medtronic is recalling its HeartWare HVAD pump outflow graft and outflow graft strain relief because of the risk of breaks and tears during the pre-implant pump assembly process. FDA has id… Read More
2020-05-28 18:40
InspectIR Systems has launched a clinical trial focused on using a mobile device for the detection of the novel coronavirus (COVID-19).
The Frisco, TX-based company began the trial on Wedne… Read More
2020-05-28 17:32
2020-05-28 14:04
Physicians and clinicians are facing the unique challenge of practicing social distancing with their patients during the COVID-19 pandemic. It seems almost impossible because the practice o… Read More
2020-05-28 14:00
Just a couple of short months ago, workplace safety was a familiar concept. The potential hazards — exposure to chemicals, proximity to machinery, ladders, and so forth &a&helli…Read More
2020-05-27 14:02
2020-05-27 10:00
(Image source: WHO)
There are two key differences between the novel coronavirus that causes COVID-19 and 5G technology. One has spread across the globe, the other has barely rolled out in… Read More
2020-05-27 06:54
Plastic swaging and staking technology is favored for many types of plastic-based assemblies because by forming a plastic post or flap, it is possible to securely connect or   Read More
2020-05-26 20:19
Philips has won a nod from FDA and a CE mark for a next-generation wireless wearable biosensor to help monitor COVID-19 patients in hospital.
The Amsterdam, Netherlands-based company touts… Read More
2020-05-26 19:27
Resolve to Save Lives, an initiative launched by global health organization Vital Strategies, released a playbook that describes four essential actions governments need to take to reopen so… Read More
2020-05-26 18:06
Bardy Diagnostics is expanding the home enrollment program for its cardiac patch monitor and won CE mark for a 14-day version of the device.
The Seattle, WA-based company said it was explor… Read More
2020-05-23 20:12
The coronavirus pandemic has caused market turmoil that has had a negative impact on medical device companies of all sizes. While the large, established medical device players like Medtroni… Read More
2020-05-22 18:32
Google and Apple Launch Highly Anticipated Contact Tracing Technology
The two tech rivals have developed the Exposure Notification technology which can inform someone if they may have come… Read More
2020-05-22 18:15
As MD+DI reported in April, Medtronic was already bracing for its fiscal fourth quarter to reflect significant revenue declines, thanks to COVID-19. Â But CEO Geoff Martha said t… Read More
2020-05-22 11:00
Motors and motion control components continue to shrink. The miniaturization trend allows manufacturers to install motors and motion control into smaller and smaller form factors. When comp… Read More
2020-05-22 09:01
Within the healthcare industry there is an understanding among medical device companies that the drive for improvements in both manufacturing and packaging is a constant. In this time of in… Read More
2020-05-21 20:03
Abbott Laboratories is slated to provide millions of IgG lab-based antibody tests to U.K. government in the latest chapter of the COVID-19 story. The Abbott Park, IL-based company has alrea… Read More
2020-05-21 19:22
As more U.S. states begin to resume elective surgeries, hospitals and medical device companies have a strong financial incentive to see procedure volumes return to normal. The t… Read More
2020-05-21 19:13
Google and Apple said they have launched the Exposure Notification technology for the novel coronavirus (COVID-19).
The technology is a software tool kit that would notify someone if they m… Read More
2020-05-21 16:45
2020-05-21 13:00
“Never let a serious crisis go to waste,†Rahm Emanuel famously said about the Great Recession when he served as the White House Chief of Staff under Pre… Read More
2020-05-20 20:11
As frontline healthcare workers across the United States continue to treat COVID-19 patients, staff at hospitals that have adopted a mobile app called Elemeno have a… Read More
2020-05-20 19:04
Verily is hoping to get a deeper understanding of the novel coronavirus (COVID-19) starting with an initial focus of antibody testing. The Alphabet company and former life sciences arm of G… Read More
2020-05-20 18:32
NFL players could be sporting helmets with full-cover face masks unlike anything fans have ever seen before in the upcoming season.
Thom Mayer, medical director for the NFL Players Associat… Read More
2020-05-19 20:35
A team of radiologists from China discussed making changes to the CT examination process during the novel coronavirus (COVID-19) pandemic. The group’s work was published i… Read More
2020-05-19 20:30
If it takes a village to raise a child, it takes an entire world to defeat a pandemic. That sentiment is becoming more evident every day as we see cross-industry collaborations and public-p… Read More
2020-05-19 20:15
Three companies under the Roche umbrella are looking to shake up the way clinical trials are conducted and better understand the patient journey during these studies.
To this end, Flatiron… Read More
2020-05-18 21:01
Certain respirators made in China may not provide consistent and adequate respiratory protection to healthcare workers exposed to COVID-19, FDA said after a number of these resp… Read More
2020-05-18 19:21
The Irvine, CA-based company said the Pascal repair system demonstrated high procedural success and significant clinical improvements in patients with challenging tricuspid anatomy and seve… Read More
2020-05-18 18:42
Microsoft and UnitedHealth Group have joined forces to support return-to-workplace planning, as the push to reopen the economy continues in the U.S.
To do this, the two companies are launch… Read More
2020-05-15 23:58
Abbott Defends Its Rapid COVID-19 Test
FDA alerted the public on Thursday that early data from independent studies suggests potential inaccurate results from using the Abbott ID NOW point… Read More
2020-05-15 14:57
FDA is still granting Emergency Use Authorization (EUA) for COVID-19 tests, even though the conversation surrounding is shifting to antibody testing.
This time Hologic has received EUA for… Read More
2020-05-15 08:19
Amid the current COVID-19 pandemic, many medical device manufacturers and suppliers are moving at unprecedented speeds to develop and enact updated risk management policies and procedures… Read More
2020-05-15 00:35
FDA took action Thursday that proves the agency is still keeping close tabs on the breast implant market, which has long been plagued with safety and regulatory problems.
FDA sent warning l… Read More
2020-05-14 23:39
This micro-podcast episode gives you the details you need most on this developing story. MD+DI will publish a full story on the issue shortly Read More
2020-05-14 20:22
A consumer survey conducted by analysts at Needham & Co. sheds some light onto what the procedure recovery could look like in the United States as hospitals in many states have begun re… Read More
2020-05-14 17:42
2020-05-14 14:00
If you’re not a healthcare provider or a worker exposed to hazardous conditions, chances are you didn’t pay much attention to personal protective equipm… Read More
2020-05-14 05:33
Not all companies are rushing to bring back employees as the country reopens for physically distanced business. Coca-Cola, headquartered in Atlanta, will keep workers home, despite loosened… Read More
2020-05-13 18:37
CardioFocus has won a nod from FDA for the next-generation HeartLight X3 Endoscopic Ablation System. The Marlborough, MA-based company said the device is used in the treatment of drug-refra… Read More
2020-05-13 16:00
The coronavirus pandemic has been one of the greatest tests for the MedTech industry in modern time. The global effects have left many industries reeling and asking questions about how thei… Read More
2020-05-13 14:32
Thermo Fisher Scientific is continuing to move fast and furious with its COVID-19 detection efforts. The firm is now collaborating with WuXi Diagnostics and Mayo Clinic to develop a new ser… Read More
2020-05-13 07:44
The EU Parliament has adopted the EU Commission’s proposal to postpone enforcement of the EU Medical Devices Regulation (MDR) by one year until May 2021. The decision to d… Read More
2020-05-12 18:28
The call for speakers for the 2021 MD&M West Conference is now open. R&D, design, product development, and process and quality engineers are encouraged to share their innovation str… Read More
2020-05-12 17:47
2020-05-12 16:00
The emergence of the SARS CoV-2 virus, which causes COVID-19, has brought to the forefront another beneficial aspect of plastics — antimicrobial and antiviral additives th… Read More
2020-05-12 15:30
Ortho Clinical Diagnostics has received CE mark for its COVID-19 total antibody test. The CE mark comes just a few weeks after the Raritan, NJ-based company was granted an emergency use au… Read More
2020-05-11 23:19
Spoken by the late and well-respected business leader Jack Welch, “Cash is King†is a mantra many business leaders live by, but what does that mean today… Read More
2020-05-11 20:16
Executives at public medtech companies won't soon forget the current earnings season. At a time of year when companies typically offer investors insight regarding annual revenue projections… Read More
2020-05-11 19:11
Researchers from the University of Washington said Abbott’s antibody test for the novel coronavirus (COVID-19) performed well in a recent independent study. The research w… Read More
2020-05-11 18:27
3D printing has emerged as a hero technology during COVID-19 because the technology enables rapid prototyping and production of personal protection equipment (PPE), diagnostic t… Read More
2020-05-11 15:33
Mayo Clinic and Ultromics are employing artificial intelligence to help rapidly assess patients diagnosed with the novel coronavirus (COVID-19).
Under the collaboration, the two will use Ec… Read More
2020-05-08 19:00
FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples.&A&helli…Read More
2020-05-08 15:24
FDA Cracks Down on Fraudulent COVID-19 Tests
The agency revised its earlier policy on COVID-19 antibody tests to cut down on false and inappropriate marketing claims that have cropped up. I… Read More
2020-05-07 18:59
What’s going to happen to the industry after the COVID-19 crisis? Take a look below to see MD+DI's Managing Editor Omar Ford break down his thoughts on the matter Read More
2020-05-07 16:50
2020-05-07 15:34
Grail, a liquid biopsy specialist, is bringing in $390 million in a series D round.
New investors including the Public Sector Pension Investment Board (PSP Investments) and Canada Pension P… Read More
2020-05-07 14:00
SARS-CoV-2, the coronavirus that causes COVID-19, has a nasty habit of lingering on surfaces for extended periods of time. For example, active virus particles were found on the Diamond Prin… Read More
2020-05-06 14:56
Fitbit is launching a large-scale virtual study to validate the use of its wearable technology to identify atrial fibrillation in patients. The San Francisco, CA-based company said it plans… Read More
2020-05-06 07:07
MedAccred continues to expand its support for the medical device industry. Described as an “industry-managed supply chain oversight program for critical manufacturing proc… Read More
2020-05-06 07:01
Sophisticated devices are being charged with delivering many of today’s novel drug therapies. To ensure patient access to such innovations, pharmaceutical companies and th… Read More
2020-05-06 01:27
For the first time in 10 years, Ian Burkhart is able to move his arm and feel what he is touching. The findings were reported late last month in the journal Cell.
Â
Burkhart, wh… Read More
2020-05-05 20:25
The weeds of misinformation about COVID-19 are tall and thick, but an update to FDA's frequently-asked questions page should clear some things up, both for test makers and the general publi… Read More
2020-05-05 20:19
Pulmonx has raised $66 million in a financing round despite a lull in procedures and a turbulent economy caused by the negative impact of the novel coronavirus [COVID-19].
The commercial-st… Read More
2020-05-05 16:04
The story for the diagnostics industry in March and April was FDA’s Emergency Use Authorization of multiple tests to detect the novel coronavirus (COVID-19).
The conversat… Read More
2020-05-05 02:54
Medical devices designed to accommodate human variability present a growing opportunity for the healthcare and life sciences industries. Historically, medicine has solved many of the â&helli…Read More
2020-05-04 22:57
The medical diagnostics industry has been moving steadily from centralized testing toward a decentralized model that brings testing ever closer to the patient. The benefits of point-of-care… Read More
2020-05-04 20:11
As the diagnostic community shifts its attention SARS-CoV-2Â antibody testing, FDA flags a concerning number of COVID-19 antibody tests marketed under false and inappropriate cla… Read More
2020-05-04 20:06
Baxter International is experiencing significant revenue growth because of the novel coronavirus (COVID-19). Because of the virus’s impact, the Deerfield, IL-based company… Read More
2020-05-04 18:13
There were some pretty significant developments in the world of COVID-19 that occurred over the weekend. One of these developments was Roche Diagnostics being granted Emergency Use Authoriz… Read More
2020-05-04 13:18
As technology has progressed, automation has been successfully introduced into several areas of healthcare practice, such as surgery and data processing, providing a range of benefits from… Read More
2020-04-30 19:47
2020-04-30 18:45
Another Deal Bites the Dust
Citing a negative market impact from COVID-19, Alphatec backed out of its agreement to acquire EOS Imaging. While the deal is no longer feasible as contemplated… Read More
2020-04-30 18:42
Abiomed, maker of the Impella heart pump, could have the chance to reach some COVID-19 patients with its latest acquisition.
The Danvers, MA-based company said it acquired Breethe, a develo… Read More
2020-04-30 04:49
The United States goverment is taking a hard look at companies that may be unethically profiting from the COVID-19 pandemic. This week a federal court in Utah entered an injunction halting… Read More
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