CMS proposes pathway to earlier breakthrough device coverage

The voluntary plan would allow manufacturers to address evidence gaps through studies designed to answer specific questions.

By Susan Kelly • Updated June 23, 2023

Owlet receives FDA clearance for prescription pulse oximetry baby sock

Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.

By Nick Paul Taylor • June 22, 2023

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Proposed breast cancer screening recommendations don’t go far enough

A proposal by a government-sponsored task force calling for a 24-month spacing between mammograms fails to address the latest research and may further exacerbate disparities and mortality outcomes, argues Henry Izawa, head of FujiFilm Healthcare Americas.

By Henry Izawa • June 21, 2023

The importance of trust in AI as a medical device

Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

By Alison Dennis • June 15, 2023

Huma hails 510(k) clearance as boost to digital health product development

The clearance permits Huma to host digital health tools from multiple creators that support screening, diagnosis, dosing recommendations and clinical decisions.

By Nick Paul Taylor • June 13, 2023

EPA’s proposed ethylene oxide regulations may cost sterilizers more than estimated: Moody’s

Large commercial sterilizers should be able to handle the increased costs, but smaller companies might have to sell, Moody’s analysts write. 

By Elise Reuter • June 9, 2023

Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade

The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

By Peter Green • June 7, 2023

FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance

William Blair analysts believe “customers are unlikely to change their usage of Zio AT [heart monitors] over time, making this a resolvable issue.”

By Nick Paul Taylor • June 7, 2023

Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.

By Peter Green • Updated June 5, 2023

AdvaMed lobbies for medtech companies to be prioritized in global supply chain

The medtech trade group published a white paper outlining supply chain improvements needed to ensure availability of materials and parts for medical devices.

By Elise Reuter • June 2, 2023

FDA hits iRhythm with warning letter over problems at heart monitor facility

iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results.

By Nick Paul Taylor • June 1, 2023

Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass

Legislation has been proposed in Congress to bring diagnostic tests under a single regulatory framework, but if it doesn’t pass, the FDA has authority to regulate lab-developed tests, the groups said.

By Elise Reuter • May 31, 2023

MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

By Nick Paul Taylor • Updated June 12, 2023

Illumina accused of ‘playing delay tactics’ to push back EU decision on divesting Grail: Financial Times

Delaying the decision to divest Grail could let Illumina sell the liquid biopsy business when the market is more favorable.

By Nick Paul Taylor • May 30, 2023

Friday Q&A: Stanford Biodesign’s Makower on expediting Medicare coverage for breakthrough devices

The director and co-founder of the Stanford Byers Center for Biodesign has been urging CMS to get patients access to breakthrough devices.

By Susan Kelly • Updated May 26, 2023

Boston Scientific cancels $230M stent deal after regulators erect barriers to acquisition

The Federal Trade Commission said Boston Scientific took the action in response to investigations by its staff and overseas enforcement partners.

By Nick Paul Taylor • May 26, 2023

FDA teams with Veterans Health Administration to make medtech supply chains more resilient

Rather than amassing reserves of physical supplies, “digital stockpiles” would create a network of trusted suppliers that have the ability to make products at or near the point of use. 

By Nick Paul Taylor • May 24, 2023

Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market

Beta Bionics’ device, aimed at people with Type 1 diabetes, has eliminated most of the data entry required by competitors.

By Nick Paul Taylor • May 22, 2023

Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk

A study found the test is a better predictor of the risk of developing preeclampsia with severe features than standard clinical measures.

By Nick Paul Taylor • May 22, 2023

FTC moves to strengthen Health Breach Notification Rule’s applicability to digital health apps

Regulators are increasingly leaning on the HBNR to crack down on the sharing of sensitive medical data, and the FTC is looking to strengthen its case.

By Rebecca Pifer • May 18, 2023

Rapid AI adoption could cause medical errors, patient harm, WHO warns, urging oversight

Warning that caution is not being exercised with use of artificial intelligence in healthcare, the World Health Organization called for rigorous oversight of the new technology.

By Susan Kelly • May 17, 2023

Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device.

By Nick Paul Taylor • Updated May 17, 2023

AdvaMed cites EPA’s own impact assessment to push back against ethylene oxide proposals

Medtech firms and environmental regulators are at loggerheads as the industry looks for a safe and cost-effective alternative to ethylene oxide for sterilizing reusable devices.

By Nick Paul Taylor • May 12, 2023

New breast cancer screening guidelines could boost mammography sales

Hologic, which makes mammography machines, could see an increase in its installed base, according to Needham analysts.

By Elise Reuter • May 9, 2023

FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech

The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.

By Nick Paul Taylor • May 9, 2023