Medical Devices
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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 at 11:18 a.m. -
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 at 10:54 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.
By David Lim , Maria Rachal • UPDATED: Aug. 16, 2019 at 3:37 p.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.
By Maria Rachal • UPDATED: Aug. 16, 2019 at 12:01 p.m. -
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.
By Susan Kelly • Aug. 16, 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 -
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.
By Nick Paul Taylor • Aug. 15, 2019 -
FDA hits medicine cabinet and cart maker Talon with warning letter
The agency found 11 violations of quality system regulations, ranging from failure to follow audit principles and perform risk analysis to inadequate procedures covering design changes and control of nonconforming products.
By Susan Kelly • Aug. 14, 2019 -
Analysts predict big jump in continuous glucose monitor use
Abbott and Dexcom are likely to dominate the CGM market in the long term. Medtronic is expected to remain the leader in insulin pumps.
By Susan Kelly • Aug. 14, 2019 -
Stryker acquires maker of device sterilization systems
The deal comes against a backdrop of heightened regulatory scrutiny of duodenoscope reprocessing after a spike in contamination cases and the closure of a Sterigenics plant in Illinois that sterilized a wide range of devices.
By Susan Kelly • Aug. 13, 2019 -
Australia weighs in on paclitaxel-coated balloons
The Therapeutic Goods Administration said data on adverse events in Australia haven't shown a signal like the one described by FDA.
By Susan Kelly • Aug. 13, 2019 -
Concept Medical nabs breakthrough designation for sirolimus-coated balloon for PAD
If granted FDA marketing authorization, the device may compete with paclitaxel devices sold by BD, Medtronic, Boston Scientific, Philips and Cook Medical.
By David Lim • Aug. 13, 2019 -
Two more notified bodies designated in EU, but pace still lags
The public database NANDO lists German company Dekra Certification as one of the two notified bodies.
By Dana Elfin • UPDATED: Aug. 14, 2019 at 9:11 a.m. -
China grants innovative device designation to Novocure's Optune
Novocure's Chinese partner now gets the opportunity for more contact with regulators and an expedited review in a market estimated at $96.3 billion this year, up from $53.6 billion in 2016.
By Nick Paul Taylor • Aug. 13, 2019 -
Ambu to pay $3.3M to settle False Claims Act allegations
The Danish medical device maker is accused of manufacturing products in China and Malaysia and knowingly selling them to U.S. government agencies in violation of the 1979 Trade Agreements Act.
By Susan Kelly • Aug. 12, 2019 -
NuVasive looks to tech pipeline, overseas expansion in bid for spine market share
Some analysts think achieving revenue growth in the mid-single digits could be a challenge, given tough dynamics in the spinal surgery market.
By Susan Kelly • Aug. 12, 2019 -
AFib device maker AtriCure to spend up to $300M in SentreHeart buyout
AtriCure announced Tuesday it completed its acquisition of SentreHeart.
By Maria Rachal • UPDATED: Aug. 14, 2019 at 9:28 a.m. -
CMS rejects industry bid to boost payments for device-based opioid alternatives
The agency said evidence submitted was plagued by potential conflicts of interest, inadequate sample sizes and lack of peer review.
By David Lim • Aug. 12, 2019 -
UBS surgeon poll points to neuromodulation market slowdown
Those surveyed predicted Medtronic would gain the most market share going forward, with Boston Scientific in second place and Abbott in third.
By Susan Kelly • Aug. 09, 2019 -
Radiology societies partner with HP on 3D printing registry
Doctors hope the point-of-care data will help determine the value of turning medical images into patient-specific surgical models.
By Nick Paul Taylor • Aug. 09, 2019
