Breast implant makers vie for customers amid Allergan recall

Even with greater awareness of cancer and chronic illness linked to breast implants, consumer interest does not appear to have waned.

By Maria Rachal • Aug. 26, 2019

Dexcom beats WaveForm's patent suit over CGM sensors

A U.S. District Court judge's decision ends the ongoing dispute between San Diego-based continuous glucose monitor maker Dexcom and WaveForm Technologies, a subsidiary of blood glucose meter manufacturer AgaMatrix.

By Dana Elfin • Aug. 26, 2019

Explore the Trendline➔

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

Big data, cybersecurity among top FDA device center priorities

Reprocessing of devices and biocompatibility are also addressed in a report intended to incorporate new tech into regulatory decisions.

By David Lim • Aug. 23, 2019

Heart attack device earns FDA's breakthrough nod

Miracor Medical began a 144-patient clinical trial in July to examine effectiveness of its device. Earlier studies ran into hurdles.

By Nick Paul Taylor • Aug. 23, 2019

Medicare draft decisions may boost Natera, Myriad tests

Cowen analysts called proposed local coverage for Natera's colorectal cancer test as "materially broader and quicker than expected," while documents on pharmacogenomic tests gave a mixed outlook for Myriad Genetics' products.

By Nick Paul Taylor • Aug. 23, 2019

FDA flags recall of Edwards TAVR delivery system tied to 1 death, 17 injuries

Analysts characterized FDA's Class I notice Thursday of Edwards' recall, based on an issue highlighted in an urgent field safety notice last month, as a noisy headline not likely to meaningfully affect revenue.

By Maria Rachal • Updated Aug. 23, 2019

Industry sounds alarm on EU single-use device reprocessing regs

There remains a risk that the European Commission will miss its November target and fail to finalize the draft policy before MDR comes into force. 

By Nick Paul Taylor • Updated Aug. 27, 2019

AdvaMed warns White House sterilization regs pose device shortage risk

The trade association's chief lobbyist told administration officials in a meeting an effective ban on ethylene oxide as a sterilant "poses an imminent public health threat through shortages of medical devices."

By David Lim • Aug. 21, 2019

ViewRay touts promising early results from localized prostate cancer trial after disappointing quarter

Weeks after cutting revenue targets for 2019, the company reported low incidence of early gastrointestinal and genitourinary toxicity in patients who received the magnetic resonance-guided radiation therapy.

By Maria Rachal • Aug. 21, 2019

FDA issues device sterilization warning letter

The notice accuses Innovative Sterilization Technologies of promoting the sterilization product in applications outside of the scope of its 510(k) clearance.

By Nick Paul Taylor • Aug. 21, 2019

FDA approves MRI labeling for Boston Scientific DBS system

CEO Michael Mahoney touted the growth of the company's deep brain stimulation products to investors during its second quarter earnings call.

By David Lim • Aug. 20, 2019

Conformis sues Zimmer Biomet over patent infringement

Knee implant maker Conformis is seeking triple damages amid its claim that Zimmer Biomet infringed multiple of its patents for patient-specific instrument systems and techniques for joint replacement surgery.

By Susan Kelly • Aug. 20, 2019

Medtronic to ramp up TAVR, robotics programs after Street-beating Q1

Building on momentum from the Mazor Robotics integration, the medtech giant teased a Sept. 24 investor day that will feature a demonstration of its forthcoming soft tissue robotic surgery platform.

By Maria Rachal • Aug. 20, 2019

Italy's IMQ fourth notified body designated in EU

The firm joins Germany's Dekra and TÜV SÜD, as well as the United Kingdom's BSI, as the only four bodies designated less than a year before the new regulations take effect in May 2020.

By David Lim • Aug. 20, 2019

Fusion-less scoliosis device from Zimmer Biomet earns HDE

Using a flexible tether implant that applies tension to correct the curvature, the device is an alternative to fusion surgery in children and adolescents, designed to preserve range of motion in the spine.

By Susan Kelly • Aug. 19, 2019

FDA approves neuromodulation device for heart failure

The system was one of the first devices to win the agency's breakthrough status, which helped accelerate development and approval, according to manufacturer CVRx.

By Susan Kelly • Updated Aug. 19, 2019

Boston Scientific closes acquisition of BTG

The medtech giant is betting that having the subsidiary will make it the "category leader" in interventional oncology tools and products.  

By Maria Rachal • Updated Aug. 19, 2019

Edwards, Medtronic win expanded indications for low-risk TAVR patients

Roughly 165,000 low-risk patients per year in the U.S., Western Europe and Japan could now be eligible for the procedure, Medtronic estimates, a population both medtechs will be keen to treat.

By David Lim , Maria Rachal • Updated Aug. 16, 2019

Tidepool CEO talks Pre-Cert era, interoperability

Amazon and Pixar software veteran Howard Look spoke to MedTech Dive about working through FDA's software development evaluation pilot and the implications of an insulin dosing app that works with many brands' devices.

By Maria Rachal • Updated Aug. 16, 2019

V-Wave gets 2nd breakthrough designation for interatrial shunt

Building on its heart failure indication, the J&J- and Edwards-backed medtech is conducting an early feasibility study of the device in patients with pulmonary arterial hypertension.

By Susan Kelly • Updated Sept. 12, 2019

Mercy expands RWE program to capture data from other providers

The expansion of the network follows real-world evidence deals with BD, Johnson & Johnson and Medtronic.

By Nick Paul Taylor • Aug. 16, 2019

UK plans for express medical products shipping service ahead of Brexit

The announcement of the shipping service comes as the government, led by new prime minister Boris Johnson, steps up no-deal scenario preparations and downplays risks.

By Nick Paul Taylor • Aug. 16, 2019

Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA

The Hearing Industries Association letter argues the device's Phase II clinical study "does not provide enough evidence of effectiveness of the self-fitting method given the study's initial reliance on professionals for fitting."

By David Lim • Aug. 15, 2019

FDA taps Type A aortic dissection stent for breakthrough program

Ascyrus Medical's leg up from U.S. regulators follows Health Canada's approval of its device for a rare but potentially fatal condition last December and CE marking in February.

By Maria Rachal • Aug. 15, 2019

Abbott poised to profit from CMS review of TMVR coverage

Analysts at Cowen estimate CMS coverage in a newly considered indication could triple the number of patients eligible for transcatheter mitral valve repair.

By Nick Paul Taylor • Aug. 15, 2019