The Latest
-
ONC in talks with Congress, White House on third-party health app privacy
National Coordinator for Health Information Technology Don Rucker said there is bipartisan interest in taking action.
-
Varian, Boston Scientific seal the deal on beads business transfer
Varian Medical Systems said Wednesday it completed the $90 million purchase of Boston Scientific's drug-loadable microspheres and bland embolic beads, a transaction key to Boston Scientific's buyout of BTG finalized Monday.
UPDATED: Aug. 21, 2019 at 5:21 p.m. -
FDA scolds diagnostic manufacturer over production practices
An early 2019 inspection of Polymer Technology Systems' operations prompted regulators to conclude the company had failed to inform FDA of certain reportable events, among other production process shortcomings.
-
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."
-
US task force expands recommended BRCA test population
The Preventive Services Task Force's update potentially boosts business for Myriad Genetics and other BRCA test makers.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
Livongo a darling of one Wall Street firm a month after IPO
"The digital health field is littered with companies that have over-promised and under-delivered," analysts at SVB Leerink acknowledge, but they made the case the startup is different.
-
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.
UPDATED: Aug. 19, 2019 at 10:54 a.m. -
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.
UPDATED: Aug. 16, 2019 at 12:01 p.m. -
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.
-
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.
UPDATED: Aug. 19, 2019 at 11:18 a.m. -
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.
UPDATED: Aug. 16, 2019 at 3:37 p.m. -
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.
-
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.
-
Heart failure shunt receives FDA's breakthrough designation
J&J Innovation and Edwards Lifesciences are among investors backing development of the implant, which aims to ease pressure on the left side of the heart and reduce buildup of fluid in the lungs in advanced heart failure patients.
-
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."
-
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.
-
Senators push HHS for details of response to DNA test scam
Lawmakers propose pre-claim review of genetic test orders to root out fraud.
-
Industry backs Australia's device identifier plan with caveats
The responses showed broad support for a unique device identification system based on global guidelines, but the Therapeutic Goods Administration also faced some pushback from J&J and Roche.
-
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.
