Policy & Regulation

Tenet sees widespread volume recovery, again raises forecast

Despite the operating challenges poised by COVID-19 in the third quarter, the for-profit health system was able to manage through the headwinds, executives said Thursday during a call with investors. 

By Samantha Liss • Oct. 22, 2021

Medtronic surgical robotics head talks Hugo, taking on Intuitive, COVID-19 challenges

Megan Rosengarten spoke to MedTech Dive about challenging Intuitive Surgical's 20-year lead in soft tissue robotics, growing global robotics usage and the stress of entering a new market amid COVID-19.

By Ricky Zipp • Oct. 20, 2021

Explore the Trendline➔

How medtechs are navigating the sales environment through the pandemic

The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.

By MedTech Dive staff

In last ditch plea to save MCIT, medtech groups suggest fixes to CMS

AdvaMed and MDMA responded to a call for feedback on the planned repeal of the Medicare Coverage of Innovative Technology pathway by proposing tweaks and new ideas to salvage it.

By Nick Paul Taylor • Oct. 20, 2021

Over-the-counter hearing aids proposed by FDA

A Cowen analyst said the policy change would allow consumer electronics manufacturers to get into the lucrative hearing aid market that has been dominated by ReSound, Sonova and William Demant. 

By Greg Slabodkin • Oct. 19, 2021

Abbott software causing COVID-19 test false positives, starts Class I recall fix

FDA said use of the tests before the problem is corrected may cause serious adverse health consequences or death, alerting laboratories to treat the results as presumptive and that they may need to be confirmed with another test.

By Nick Paul Taylor • Oct. 19, 2021

Philips sees sleep business recovering from recall in H2 2022, analysts doubtful

William Blair analysts warn that limited provider support during the medtech's recall is hurting brand credibility and impacting Philips' ability to regain market share, while positioning ResMed as the beneficiary of "durable" share loss. 

By Greg Slabodkin • UPDATED: Oct. 22, 2021 at 11:30 a.m.

Anatomy of a medical device recall: How defective products can slip through an outdated system

"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.

By Ricky Zipp • Oct. 18, 2021

Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

The agency is mulling the types of information medtechs might include in labeling for such devices to support transparency. A Philips rep cautioned about the pitfalls of "information overload."

By Greg Slabodkin • Oct. 15, 2021

Biden circling former FDA chief Califf to again lead agency: report

The Washington Post reported the administration was "closing in" on the choice, citing unnamed sources. Still, the White House declined to comment and Califf could face opposition from Senate Democrats.

By Ricky Zipp • Oct. 15, 2021

The European Commission has caved to pressure on extending IVDR. Now what?

The EC's proposal creates a new set of timelines for the industry to meet and questions to consider — assuming it passes into law without further changes.  

By Nick Paul Taylor • Oct. 15, 2021

Boston Scientific, Sterigenics potential targets of EPA ethylene oxide reporting requirements

The agency has written to the operators of 31 medical device sterilization facilities, outlining its plans and requesting information to inform its final decision.

By Nick Paul Taylor • Oct. 14, 2021

Withings gets FDA nod for AFib-detecting wearable, taking on Apple

The device, which is capable of detecting atrial fibrillation, combines an analog watch face with health features found in digital smartwatches. The French company joins Apple, Fitbit and Samsung in a crowded market.

By Nick Paul Taylor • Oct. 13, 2021

FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response

The agency gave the designation to Quanterix's blood test, which has the potential to aid evaluation of people who present with cognitive impairment, and Nonagen Bioscience's non-invasive bladder cancer test.

By Nick Paul Taylor • Oct. 12, 2021

European Commission adds 2 modules to delayed Eudamed database, with no follow-on timeline

Sections on UDI/device registration, and Certificates and Notified Bodies are now available for voluntary use but some features are missing.

By Nick Paul Taylor • Oct. 12, 2021

Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff

The system will hit the European market after the medtech giant unveiled it in 2019 and delayed the timeline amid the pandemic. Medtronic will take on market leader Intuitive Surgical and an upcoming product from J&J.

By Ricky Zipp • Oct. 11, 2021

FDA beefs up surgical stapler oversight after injuries, death reports

While medtechs like J&J and Medtronic backed the broad change, the final rule held firm on several contentious elements. The agency also updated labeling guidance of both staplers and staples due to patient safety risks.

By Nick Paul Taylor • Oct. 08, 2021

How Morgan Health hopes to finally move the needle on employer health costs: 5 insights from a chat with the venture's CEO

Morgan Health learned a lot from Haven, but is a different beast with better knowledge of the buy-in needed to disrupt the health benefits space, CEO Dan Mendelson told Healthcare Dive.

By Rebecca Pifer • Oct. 08, 2021

Will a software bill of materials help or hurt medical device cybersecurity?

President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.

By Greg Slabodkin • Oct. 07, 2021

Labcorp, PerkinElmer latest to target COVID-flu combo test market

FDA gave a nod to Labcorp's diagnostic, which uses a Roche test for SARS-CoV-2, influenza A and influenza B. PerkinElmer's assay also got emergency authorization for those three viruses as well as respiratory syncytial virus.  

By Greg Slabodkin • Oct. 07, 2021

False positives spur Ellume recall of COVID-19 tests from DoD, retailers

The company, which got a $231 million defense contract in February, identified a manufacturing issue and has implemented "additional controls." The move comes as the U.S. races to boost the nation's supply of antigen tests.

By Nick Paul Taylor • Oct. 06, 2021

EU shares guide to MDR's 22 rules for classifying medical devices

If a manufacturer and notified body dispute a classification, the case may be referred to the competent authority in the country where the company has its registered place of business.

By Nick Paul Taylor • Oct. 06, 2021

Medtronic expands 2 MiniMed insulin pump recalls on ring flaw, cyber risks

The recalls have hit the medtech giant at a time when competitors Insulet and Tandem are ramping up in the insulin pump market and amid flagging sales in its diabetes unit.

By Susan Kelly • Oct. 05, 2021

FDA resists industry push to nix De Novo inspections in final rule

"The most controversial aspect was FDA's provision for ... an FDA inspection for what is tantamount to a 510(k)," noted Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green.

By Nick Paul Taylor • Oct. 05, 2021

Doctors slam surprise billing rule that details dispute resolution process

Making a health plan's "qualifying payment amount" the primary factor in independent dispute resolution arbitration will "cause large imaging cuts and reduce patient access to care," the American College of Radiology said.

By Shannon Muchmore • Oct. 05, 2021

Acon gets FDA nod for home COVID-19 test kit amid surging US demand

The diagnostics maker secured authorization for its over-the-counter antigen test amid a nationwide testing shortage. Abbott and Quidel are scaling up production but it could take months to boost output.

By Nick Paul Taylor • Oct. 05, 2021