Page 2
-
Boston Heart to pay $26.7M to settle alleged doctor kickback scheme
Allegations against the clinical diagnostics company included that it made payments to doctors disguised as investment returns in exchange for referrals.
-
Mandatory CMS radiation oncology model goes on the backburner
Originally, the agency was eying an implementation date as early as Jan. 1, but the new regulatory agenda lists July 2022 as a target date for the bundled payment model.
-
With 6 months until new EU medical device rules, what's the state of play?
Several deadlines have already been extended amid calls from various parties to push back implementation. But a wholesale delay is unlikely given the extensive legislative steps that would be required.
UPDATED: Nov. 26, 2019 at 12:10 p.m. -
FDA approves J&J spinout's device for kids with recurring ear infections
The agency heralded Tusker Medical's ear tube delivery system as the first for use in young children with local anesthesia in a doctor's office, which could widen treatment access for a "susceptible patient population."
-
Standards body urged to add device identifiers to insurance claims forms
Incorporating unique device identifiers into claims documents is expected to improve patient safety and save the healthcare system money by allowing better tracking of implants by brand and model.
-
Q&A5 insights into Dexcom's year ahead from CEO Kevin Sayer
The diabetes tech giant has "not turned on the faucet full blast" in marketing to new customers. Sayer told MedTech Dive he plans to change that as Dexcom quadruples its sensor production capacity for its continuous glucose monitors.
-
Medtronic warns of fault with MiniMed insulin pumps
The structural fault could cause too much or too little insulin to be delivered. The issue stems from the loss of or damage to the retainer ring, which Medtronic said can break if the pump is dropped or bumped.
-
FDA launches pilot to speed new ethylene oxide sterilization methods
Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.
-
Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis
Antibiotic resistance was higher in hospital-associated infections linked to use of devices like central lines, ventilators and urinary catheters, according to data collected from more than 5,600 sites between 2015 and 2017.
-
AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs
A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.
-
Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV
The approval allows Medtronic to sell the paclitaxel-coated balloon as a treatment for failing arteriovenous access in dialysis patients.
-
Merit Medical stent graft system gains breakthrough status
The regulatory leg up for the endoprosthesis for hemodialysis patients comes after a quarter that fell short of Wall Street's expectations.
-
Rare medical device ban, OTC hearing aids make FDA year-end to-do list
Medical device manufacturers concerned about a federal crackdown on commercial ethylene oxide sterilizers can breathe a sigh of relief as the EPA says a timeline for final regulations remains to be determined.
-
Pulmonary hypertension common in MitraClip patients, increasing mortality risk: JAMA Cardiology
After reviewing more than 4,000 cases of mitral valve repair, researchers proposed exploring intervention with devices like Abbott's MitraClip earlier in disease progression to improve outcomes.
-
Hologic unloads underperforming Cynosure medical aesthetics unit
"This divestiture was a long time coming and puts an end to a bad marriage," William Blair analyst Brian Weinstein said of Hologic's $1.6 billion deal in 2017. Now, the company expects $138 million in cash proceeds from its sale.
UPDATED: Nov. 21, 2019 at 10 a.m. -
Transcatheter device to treat heart failure gets breakthrough designation
BioVentrix is enrolling 120 subjects in a clinical trial meant to support U.S. marketing authorization for its minimally invasive alternative to conventional surgical ventricular reconstruction.
-
LivaNova to shutter mitral valve replacement line
The London-based medtech couldn't keep up with growing competition from transcatheter mitral valve repair devices and said restructuring its heart valves segment was necessary. About 150 employees could be affected.
UPDATED: Nov. 20, 2019 at 1:24 p.m. -
FDA flags 2 more deaths, over 60 device failures tied to heart balloon pump
As a software upgrade is in the works for Getinge's Maquet/Datascope intra-aortic balloon pump devices, FDA is still trying to determine what is causing the system to shut down while operating on battery power.
-
Asian private equity group to buy Lumenis in $1B deal
The maker of minimally invasive devices used in aesthetic procedures competes with rivals like Candela Medical.
-
Carolina Liquid gets FDA warning over sale of unauthorized reagents
FDA said Carolina Liquid distributed Class I and II IVD reagents without regulatory clearance. The warning is the latest in a series of letters issued this year to companies for distributing devices without premarket approval.
-
Incoming Medtronic CEO to prioritize 'aggressive' tuck-in M&A, 'reinvigorating' diabetes unit
Growth accelerated for Medtronic in its recent quarter but competitive pressures in areas like arrhythmia management and diabetes had president and future CEO Geoff Martha pledging to "get back to share-taking mode."
-
Edwards has edge over Medtronic in TAVR registry studies
The data presented at the American Heart Association meeting favor Edwards' Sapien valve, but confounding factors may explain the differences. Large, randomized trails are needed to generate more evidence, cardiologists said.
-
AdvaMed wants FDA to define 'significantly' improved for Safer Technologies Program eligibility
Although the trade association said it supports efforts to speed safer medical devices to market, it believes the agency's draft guidance lacks the specificity needed for industry to understand which devices would be eligible.
-
FDA approves 1st contact lens to slow myopia in children
Concentric rings in the lens focus light in front of the retina in a process that is thought to reduce the stimulus that causes myopia to advance.
-
In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped
The study seemed to favor a conservative approach to treating stable heart disease. But many sell-side analysts called results expected, predicting they won't meaningfully hurt sales for device makers like Boston Scientific.
Home
