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Philips’ latest BiPAP machine recall labeled Class I event by FDA

Certain bi-level positive airway pressure devices feature plastic that could cause machines to stop working suddenly, potentially leading to serious injury or death, the FDA said Friday.

Puerto Rico-based lab ceases COVID-19 test; FDA revokes EUA

The FDA disclosed the action alongside updates to the instructions for use for Thermo Fisher Scientific’s TaqPath COVID-19 test.

Friday Q&A: Scripps’ Jay Pandit talks about wearables, decentralized trials and what’s next for digital health

As wearables confirm their ability to collect data, the big question is what to do with it all. And the next technical challenge: improving wrist-based blood pressure monitors.

Device makers with ethylene oxide facilities at risk of lawsuits after Sterigenics loss: Needham

The $363 million award in the Sterigenics lawsuit “could lead to increased aggressiveness on the part of attorneys,” Needham analysts warned in a Friday note to investors.

FDA user fee package to be included in Congress’ bill to fund government, avoid shutdown, Senators say

A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to a funding bill later this year. 

Forget oximeters, smartphone cameras detect 79% of cases of low blood oxygen in small study

If the results are validated by wider studies, physicians will have a new tool to increase the number of people who can be monitored for chronic and acute respiratory conditions. 

Medtronic gets first FDA approval for drug-eluting stent in bifurcation lesions

Researchers have found the one-device, provisional stenting method delivers better results than two stents in some patients.

Diabeloop’s insulin algorithm shows 17-point rise in time-in-range from year-long patient study

About half of the people using its device achieve the recommended outcomes, versus 27% of those using standard treatment.

Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules

HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.

Abbott’s FreeStyle Libre linked to 67% drop in hospitalizations for Type 2 diabetes patients: study

After switching to the continuous glucose monitor, patients had fewer acute diabetes-related events such as severe hypoglycemia and diabetic ketoacidosis.

Insulet’s Omnipod 5 gains CE Mark for European release

After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.

As deadline for FDA user fees bill nears, Congress weighs continuing resolution

Reauthorization bill is likely to pass before Sept. 30, but it’s unclear what provisions will be included in the final version, experts said.

Updated Sept. 22, 2022

Medtronic issues urgent notice about MiniMed insulin pump system vulnerability

Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.

Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff

Sterigenics has more than 760 lawsuits pending against it in the local court for toxic emissions previously emitted by the plant.

J&J opens new research hub near San Francisco

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

Zimmer Biomet gets FDA clearance for Identity shoulder system

Ivan Tornos, the company’s chief operating officer, said in August that it would be Zimmer’s biggest shoulder launch in five years.

Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts

Medtech management teams expect fewer problems than after Hurricane Maria in 2017, noting that Hurricane Fiona is less severe and companies are better prepared.

Abbott’s latest Amulet-Watchman data show more mixed results for the heart devices

The latest head-to-head trial adds to the growing rivalry between Abbott and Boston Scientific in the left atrial appendage closure space.

FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports

The FDA provided more detailed recommendations on preventing and responding to airway obstruction that may occur when using some Medtronic endotracheal tubes.

Medtronic starts full US commercial release of updated Evolut TAVR system

Medtronic expects the device’s new features to increase its share of the multibillion-dollar heart valve replacement market.

Edwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease

Continued staffing shortages at hospitals are delaying the non-invasive aortic valve procedures for patients in need. 

Racial bias in pulse oximeters to be subject of FDA panel

The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.

Edwards gets FDA nod for mitral regurgitation treatment

The approval would bring a U.S. competitor to rival Abbott’s MitraClip device. 

Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks

The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.

FBI warns of cyber risks from legacy medical devices

Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.