House committee passes 6% increase in FDA funding

The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.

By Nick Paul Taylor • June 5, 2019

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approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.

By David Lim • June 4, 2019

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New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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.

By Susan Kelly • June 4, 2019

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.

By Susan Kelly • June 4, 2019

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.

By Maria Rachal • June 4, 2019

EMA posts draft guidance on drug-device combinations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.

By Nick Paul Taylor • June 4, 2019

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.

By Susan Kelly • June 3, 2019

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.

By Susan Kelly • June 3, 2019

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.

By Susan Kelly • June 3, 2019

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.

By Maria Rachal • May 31, 2019

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.

By Maria Rachal • May 31, 2019

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.

By Susan Kelly • May 31, 2019

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.

By David Lim • May 31, 2019

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. 

By Nick Paul Taylor • May 31, 2019

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.

By Shannon Muchmore • May 30, 2019

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.

By Nick Paul Taylor • May 30, 2019

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.

By Nick Paul Taylor • May 30, 2019

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.

By Nick Paul Taylor • May 30, 2019

Health Canada makes it official: Macrotextured breast implants off the market

Regulators concluded Allergan's Biocell surface implants boost the risk of developing cancer, outweighing potential benefits. The decision conflicts with FDA's stance citing insufficient evidence to support a U.S. ban.

By Maria Rachal • May 29, 2019

FDA experts meet to mull up-classing surgical staplers

Thursday's advisory panel meeting comes amid identification of adverse tissue reactions, infections and complications associated with device malfunction and user error — and 412 reports of death.

By Maria Rachal • May 29, 2019

Test for Parkinson's wins FDA breakthrough designation

Developer Amprion's research focuses on the alpha-synuclein protein as a potential biomarker of the disease.

By Susan Kelly • May 29, 2019

IMDRF posts guidance on custom-made device exemptions

The text covers the eligibility of products for custom-made device pathways and the rules governing such technologies.

By Nick Paul Taylor • May 29, 2019

Neurostimulators could be good match for stroke patients, study suggests

Researchers said a device that aims to increase blood flow to the brain after stroke holds potential for improving functional outcome in patients, although the trial results did not reach statistical significance.

By Susan Kelly • May 28, 2019

FDA clears endoscope connector to prevent fluid backflow

Erbe USA redesigned its device after FDA said the lack of a mechanism to prevent patient fluids from flowing backward and contaminating the irrigation system raised infection risks.

By Susan Kelly • May 28, 2019

Neuromodulation patch for migraine gains De Novo nod

The wireless device from Theranica Bioelectronics requires a prescription and is self-administered at home at the onset of migraine headache.

By Susan Kelly • May 28, 2019