Medical Devices

FDA walks back new device class definitions after industry blowback

AdvaMed and the Medical Device Manufacturers Association scored a temporary win after arguing the proposed revisions to the Class III definition could shift more devices into the high-risk category.

By David Lim • Dec. 14, 2018
Medtech industry cheers as NAFTA 2.0 edges forward

Trade groups heralded improved transparency in the recently-signed USMCA, which includes a provision that would enforce more timely reimbursement decision-making by national bodies.

By Nick Paul Taylor • Dec. 14, 2018
FDA touts progress in move toward global device audits

Participating manufacturing sites have spiked this year with 2,629 cumulatively added as of the third quarter of 2018, up from 777 at the end of 2017.

By David Lim • Dec. 13, 2018
FDA adds information on device BLAs to user fee guidance

The revised document features additional information on the fees for device biologics license applications.

By Nick Paul Taylor • Dec. 13, 2018
FDA rates GE ventilator safety guard recall as Class I event

The recall was triggered after the tech giant discovered the device has the potential to disconnect from the patient's breathing circuit.

By Nick Paul Taylor • Dec. 13, 2018
Apple EKG, artificial iris among FDA 2018 device decisions

De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.

By Meg Bryant • Dec. 12, 2018
Boston Scientific scores US victory in TAVR patents battle

A jury in the U.S. District Court for Delaware determined that the Sapien 3 device from Edwards Lifesciences infringed a Boston Scientific patent in the hotly contested transcatheter aortic valve replacement systems market.

By Maria Rachal • Dec. 12, 2018
UK readies 'worst-case' Brexit plan for medical devices

The government issued an update on its contingency planning if no deal is reached by March 29 for the country to remain part of the EU medicines and medical devices regulatory networks.

By Susan Kelly • Dec. 12, 2018
HIMSS: Health coaching could boost value of wearables

HIMSS surveyed 101 health IT and hospital administrators for the Fitbit-sponsored report, which found that half of hospitals and health systems were already implementing health coaching, or planned to do so.

By Susan Kelly • Dec. 12, 2018
Hospital beds from Hill-Rom get sensor tech

Sensors continually check patients' heart and respiratory rates and alert providers if their vital signs change.

By Meg Bryant • Dec. 11, 2018
Hologic begins selling 3-in-1 uterine scope

The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.

By Susan Kelly • Dec. 11, 2018
Duodenoscope studies find higher-than-expected contamination rate, FDA says

Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled devices were contaminated with microorganisms including pathogenic strains such as E. coli.

By Nick Paul Taylor • Dec. 11, 2018
Cybersecurity priorities laid out by key House panel

The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity vulnerabilities with a focus on medical devices in healthcare.

By Susan Kelly • Dec. 10, 2018
FDA clears Contego Medical peripheral angioplasty system

The catheter-based device for use in procedures to treat peripheral artery disease incorporates an adjustable filter to capture blood clots and is intended for high-risk patients.

By Susan Kelly • Dec. 10, 2018
FDA to revisit transvaginal mesh issues at February meeting

The agency said it may consider additional regulatory actions based on public feedback and Feb. 12 advisory panel discussions.

By Susan Kelly • Dec. 10, 2018
UPenn surgeons perform first robot-assisted bilateral breast reconstruction

The physicians used Intuitive's da Vinci system to increase the precision of the minimally-invasive procedure.

By Nick Paul Taylor • Dec. 07, 2018
Device industry 2019 outlook beats hospitals, pharma: Moody's

The credit ratings agency said the sector will benefit from new product innovation and demand from emerging markets, but could face headwinds from rising trade tensions and the reinstatement of the medical device tax in 2020.

By Susan Kelly • Dec. 07, 2018
Edwards expects TAVR demand to fuel double-digit growth in 2019

The company predicts 11% to 15% TAVR growth for the second year in a row.

By Nick Paul Taylor • Dec. 06, 2018
FDA seeks to boost use of De Novo pathway with proposed rule

The increased clarity intended for the regulatory framework and application process could incentivize manufacturers to establish new predicates, aligning with the agency's plan to phase out older ones.

By Maria Rachal • Dec. 05, 2018
ResMed buys maker of COPD, asthma monitoring platform

The acquisition of Propeller follows a growing trend by device makers to acquire or partner with digital technology companies.

By Susan Kelly • Dec. 05, 2018
Medtronic subsidiary to pay $17.9M in DOJ settlement

Following a federal probe, Medtronic-owned medical device company ev3 pleaded guilty to charges related to marketing a neurovascular medical device for unproven and potentially dangerous uses.

By Maria Rachal • Dec. 05, 2018
FDA classifies Medtronic's ventilator correction a Class I recall

The software update addresses user interface problems that led Australian regulators to suspend the device.

By Nick Paul Taylor • Dec. 05, 2018
OIG finds Medicare overpaid $34M to device suppliers over three years

The overpayment stems from improper billing for prosthetics and other devices used at inpatient facilities.

By Nick Paul Taylor • Dec. 05, 2018
Medtronic AFib study combines hot, cold ablation techniques

Atrial fibrillation treatments are a high-growth business for Medtronic, which competes against Boston Scientific and Abbott in the $4 billion market.

By Susan Kelly • Dec. 04, 2018
Medtech R&D adapting under new pressures, industry study shows

The shift to value-based payment models and already tight profit margins are ratcheting up pressure, but the device makers are adjusting their R&D investment strategies in response.

By Susan Kelly • Dec. 04, 2018