FDA seeks more power for medical device cybersecurity mandates

CDRH wants to require medtechs to have a Software Bill of Materials ready upfront as part of a premarket submission, as well as the capability to update and patch device security into a product's design.

By Greg Slabodkin • Aug. 17, 2021

Boston Scientific's vaginal mesh studies entrench FDA's view that risks outweigh benefits

After halting sales of the product in 2019, the regulator said the additional risks associated with transvaginal mesh repair mean it "continues to believe that these devices do not have a favorable benefit-risk profile."

By Nick Paul Taylor • Aug. 17, 2021

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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

Amid delta surge, Thermo Fisher EUA for COVID-19 assays seeks to compensate for variants

FDA in January said accuracy of PCR tests from Thermo Fisher and others may be affected by variants. Testing chief Tim Stenzel said the agency is working to ensure EUA-authorized tests are still performing amid virus mutations.

By Greg Slabodkin • Aug. 16, 2021

Abbott's Amulet FDA approval sets stage for US market fight with Boston Scientific

The atrial fibrillation device will challenge Boston Scientific's Watchman in a market valued at $500 million. Abbott plans to release a head-to-head study with its rival at the end of the month.

By Ricky Zipp • Aug. 16, 2021

Medtechs need to up their cybersecurity threat modeling game, FDA says

The agency "will be looking for much more detailed and comprehensive" cyber threat models as part of premarket review, said Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technology Innovation.  

By Greg Slabodkin • Aug. 13, 2021

US now a priority market for most developers of novel devices, FDA survey finds

CDRH topped its goal to boost the percentage of manufacturers that target the U.S. market at least at the same time as rival regions.

By Nick Paul Taylor • Aug. 13, 2021

NESTcc seeks feedback on active postmarket medical device surveillance system

The National Evaluation System for health Technology plans to work with a contractor to test real world scenarios for devices such as ventilators, robotic surgery, breast implants and fully disposable duodenoscopes.

By Nick Paul Taylor • Aug. 13, 2021

Boston Scientific gets FDA nod for single-use bronchoscope, sees $2B opportunity

The medtech giant is targeting a potentially lucrative market but will face competition from rivals with a longer history in the space, including Ambu and Olympus. A limited U.S. release of the device is set for the coming weeks. 

By Nick Paul Taylor • Aug. 11, 2021

'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices

The agency said the "shorter term data with greater reliance upon intermediate and surrogate outcomes" used to bring devices to market is "generally less helpful" for its assessments.

By Nick Paul Taylor • Aug. 11, 2021

Digital therapeutics — a double-edged sword?

Aloha McBride, EY's global health leader, argues that algorithms need to be regularly audited and screened for bias and discrepancies, while clinicians play a vital role in explaining the key features of apps and patient privacy risks.

By Aloha McBride • Aug. 10, 2021

Delaware tries capping hospital price growth to fund more primary care

A multi-pronged bill also forces certain payers to tie nearly half of their business to alternative payment models by 2023, and create shared accountability for both the cost and quality of care.

By Samantha Liss • Aug. 9, 2021

5 must-watch panels at an unprecedented HIMSS21

Masks and proof of vaccination will be required on the ground in Las Vegas, and a corresponding digital event will also take place.

By Rebecca Pifer • Aug. 9, 2021

FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line

The medtech giant took the action after discovering devices, once hailed as a growth driver, can incorrectly enter safety mode, putting patients at risk of serious injury.

By Nick Paul Taylor • Aug. 9, 2021

FTC warns it may challenge deals later as it's hit by 'tidal wave' of merger filings

"Companies that choose to proceed with transactions that have not been fully investigated are doing so at their own risk," the regulator said.

By Samantha Liss • Aug. 5, 2021

Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel

One expert said there's "compelling evidence that [Keystone Heart] not only didn't demonstrate efficacy, but there's a potential signal of harm."

By Nick Paul Taylor • Aug. 4, 2021

Philips ventilator recall labeled Class I by FDA, second in as many weeks

The recall was triggered by identification of a risk that ventilators will provide lower oxygen flow. The Class I event is separate from FDA's designation in July of a recall impacting millions of Philips sleep apnea and ventilator devices.

By Nick Paul Taylor • Aug. 4, 2021

Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic

Comments "overwhelmingly supported" the plan to use pre-pandemic data on the cost of inpatient stays to inform CMS' rates for fiscal 2022.

By Nick Paul Taylor • Aug. 3, 2021

FDA ups premarket application user fees by 2.5% for FY 2022

The base PMA fee will be $329,000, though the increase is far less than the 7% hike instituted last year.

By Greg Slabodkin • Aug. 2, 2021

Digital health, heart disease devices feature in latest FDA breakthrough designations

Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.

By Nick Paul Taylor • Aug. 2, 2021

Patient deaths called 'injury,' 'other' in FDA medical device database: study

The analysis raises questions about the complex reporting system. FDA has reached out to the lead author for reports believed to be misclassified to perform its own evaluation.

By Ricky Zipp • Updated July 30, 2021

COVID-19 impact on US healthcare system will stretch for decades, Fitch says

Over the long term, hospitals will face increased pressure from tight labor and wage markets, especially for experienced staff, as well as rising pharmaceutical and supply chain costs, the ratings agency warned.

By Shannon Muchmore • July 29, 2021

Mayo Clinic named U.S. News top hospital for sixth straight year

The list, which already examines specialty areas like knee replacements, added seven new measures including care for spinal fusion and hip fracture.

By Shannon Muchmore • July 28, 2021

Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

By Nick Paul Taylor • July 26, 2021

FDA labels Philips sleep apnea, ventilator recall Class I, ResMed eyes advantage

The agency notices come about one month after Philips announced the recall and began pulling machines from the market. Rival ResMed said there has been a "considerable increase in demand" for its products since the recall.

By Ricky Zipp • Updated July 23, 2021

Illumina-Grail merger subject of in-depth EU antitrust probe

European officials opened a three-month investigation of the deal, valued up to $8 billion, due to concerns it may reduce competition in the emerging liquid biopsy market. Illumina vowed to press on.

By Nick Paul Taylor • July 23, 2021