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Apple Watch, mesh slings among new NESTcc projects

The real-world evidence hub selected 12 new test cases to evaluate its model in medical device regulatory and clinical decision-making. 

Executives expect AI to transform healthcare within 3 years

Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.

Muscle relaxation app helps calm migraine in small NYU study

Migraine sufferers who used the smartphone app at least twice a week had four fewer headache days per month on average.

LabCorp says 7.7M patients exposed in same data breach as Quest Diagnostics

The company Wednesday also announced Adam Schechter, current lead independent director of LabCorp's board and longtime Merck executive, will replace David King as CEO Nov. 1.

Device industry praises FDA AI/ML framework, asks for Class III software inclusion

AdvaMed and the Combination Products Coalition applauded the agency's work on a regulatory approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.

Beckman Coulter buys Cytobank to add data analysis software

The Danaher-owned company said the software will complement its flow cytometer and help manage more complex workflows.

OIG issues alert on genetic testing scam

Scammers are trying to get personal information from Medicare beneficiaries by offering genetic testing through telemarketing calls, booths at public events, health fairs and door-to-door visits.

EMA posts draft guidance on drug-device combinations

The European Medicines Agency published the text to inform companies of their obligations under the regulations set to come into force across the continent next year.

UK regulators discourage use of paclitaxel devices to treat intermittent claudication

The notice is the latest signal of caution surrounding paclitaxel-eluting stents and coated balloons, coming two weeks before FDA is set to scrutinize the class of devices in a two-day meeting.

Apple Watch's newest health addition: menstrual cycle tracking

With Apple emphasizing information encryption, the cycle tracking feature could impact established smartphone-based apps like Clue and Flo.

Donor lung preservation system gains expanded indication

The approval allows TransMedics' lung preservation technology to be used for donor lungs initially deemed unacceptable for transplant due to the limitations of traditional cold storage.

11.9M Quest Diagnostics patients potentially exposed to data breach

Financial, medical and other personal information, such as Social Security numbers, may have been exposed, the company reported Monday morning.

Device makers could feel pinch from Mexico tariffs

Medtech companies with manufacturing facilities in Mexico include Intuitive Surgical, Medtronic, Stryker and Teleflex, according to analysts.

Multi-cancer blood test shows early promise at ASCO

Grail, with backers including Amazon, Bill Gates, Alphabet venture arm GV, J&J and Celgene, said it would move forward with testing based on positive early data presented in a poster at the cancer meeting.

Roche, GE Healthcare partner on software for tumor boards

The companies expect that combining patient images and data in one location will help cancer teams decide on diagnosis and treatment plans more quickly and efficiently.

FDA, industry, advisers say surgical staplers warrant premarket review

Medtronic's Covidien and Johnson & Johnson's Ethicon supply the staplers commonly used in minimally invasive surgeries. The devices will almost certainly be moved to Class II, but special controls are not yet finalized.

DME industry ramps up lobbying efforts ahead of 2020 proposed rule

Key health lawmakers in the House and Senate are lending support to AAHomecare in its bid to prevent CMS from adding non-invasive ventilators to its competitive bidding program in 2021.

Wearable glucose monitor wins CE mark, as market gets crowded

Nemaura Medical said it intends for its disposable SugarBeat adhesive patch system to compete aggressively on price.

GS1 updates UDI guideline to reflect changes to FDA position

Among the almost 20 new subsections added by GS1 are several intended to help device companies get started with UDIs. 

Medtech groups call for immediate action to avoid EU regulatory cliff

The trade groups think the system is "very unlikely" to be ready in time, raising fears of severe supply disruption.

Resolution lands FDA breakthrough nod for liquid biopsy

The company says Resolution HRD could be the first approved test of its kind capable of detecting gene deletions from cell-free DNA.

FDA consults surgical device experts on down-classing certain hemostatic agents

Johnson & Johnson's Ethicon opposes loosening premarket requirements for the devices, maintaining strict controls are needed to ensure patient safety.

Medtronic gets FDA greenlight to expand His-bundle pacing portfolio

The catheter system is designed to address the challenges of His bundle anatomy by giving physicians more maneuverability and an adjustable form.

WannaCry malware still hitting healthcare organizations

About 40% of healthcare delivery organizations have experienced at least one WannaCry attack in the past six months, largely because of older, unmanaged devices that are difficult to patch, according to cybersecurity firm Armis.

Philips' 3-year data links drug-coated balloon to sustained benefits

The company's low-dose paclitaxel-coated Stellarex beat or matched uncoated balloons on key endpoints, including rates of primary patency and mortality.