Medical Devices
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5 medtech trends to track in 2020
With the medical device tax in the rearview mirror, industry worries include the uncertain future for product sterilization, the "valley of death" between product authorization and reimbursement, and enforcement of new EU regulations.
By Maria Rachal , David Lim • Jan. 17, 2020 -
Virtual, augmented reality in medicine pique FDA's interest
The agency scheduled a March meeting that will bring together regulators, researchers, big tech and health startups as it looks to better evaluate extended reality medical products.
By Nick Paul Taylor • Jan. 17, 2020 -
Edwards' US patent challenge to Abbott MitraClip IP denied
In a decision Thursday, the Patent Trial and Appeal Board thwarted Edwards Lifesciences' petition arguing certain Abbott mitral valve repair claims are unpatentable, the latest in a transatlantic battle between the companies.
By Nick Paul Taylor • Jan. 17, 2020 -
Dexcom talks up Type 2 market, Medtronic says it has 'work to do' in diabetes at JPM
The San Francisco conference featured presentations from most major insulin delivery and glucose monitoring players, preceded by a handful of new funding announcements including a $93 million Series C for Virta Health.
By Maria Rachal • Jan. 16, 2020 -
Study of Abbott's HeartMate 3 points to single treatment indication for LVADs
A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.
By Nick Paul Taylor • Jan. 16, 2020 -
ResMed pays $37.5M to settle false claims allegations
The settlement covers accusations that the sleep apnea and respiratory conditions medical equipment maker provided free and below-cost products and services to spur patient referrals.
By Nick Paul Taylor • Jan. 16, 2020 -
REVA files for bankruptcy after bioresorbable scaffold flops
The company pinned its failure to grow sales on the European Society of Cardiology's preference for conventional drug-eluting stents.
By Nick Paul Taylor • Jan. 16, 2020 -
Amid Q4 letdown, Boston Scientific aims for $1B mark in structural heart
CEO Mike Mahoney, speaking at the J.P. Morgan Healthcare Conference, partly blamed underperformance on a December slowdown in the U.S. defibrillator business, but said the company is still sorting out reasons for the softness.
By Susan Kelly • Jan. 15, 2020 -
Health IT to lead 2020 deals, KPMG predicts
The repeal of the medical device tax could boost investor interest in hot areas like non-invasive diagnostics, robotic surgery and AI-enabled devices, although health IT, pharma and biotech appear to be drawing more excitement.
By Linda Wilson • Jan. 15, 2020 -
ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations
A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.
By Nick Paul Taylor • Jan. 15, 2020 -
Medtronic at JPM: More tuck-ins under Martha and key trial results ahead
Incoming CEO Geoff Martha also said management agrees "certain pockets of the company probably have a little bit too much bureaucracy."
By Maria Rachal • Jan. 14, 2020 -
Robotic surgeries surge to 15% of all procedures, despite limited evidence
Robot-assisted procedures jumped from accounting for 1.8% of all general surgeries in 2012 to 15.1% in 2018. Closer monitoring is needed to ensure clinical benefits and safety are prioritized, researchers said.
By Susan Kelly • Jan. 14, 2020 -
RTI Surgical inks $490M deal to sell OEM unit to private equity
The divestiture will turn Michigan-based RTI into a pure play spine company with up to $200 million in cash, as private equity groups show growing interest in the medical technology sector.
By Nick Paul Taylor • Jan. 14, 2020 -
Nevro, NuVasive, Integra, others preview earnings at JPM
Wednesday's lineup of medtech presenters includes Exact Sciences, Intersect ENT, ICU Medical and handheld ultrasound device maker Butterfly.
By Maria Rachal • UPDATED: Jan. 15, 2020 at 9:20 a.m. -
FDA guidance on catheters zeros in on testing, coatings
The agency wants to see consistency across 510(k) submissions for various types of Class II percutaneous transluminal angioplasty balloon catheters.
By Susan Kelly • Jan. 13, 2020 -
Enrollment has ended in Essure postmarket study, FDA says
Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.
By Susan Kelly • Jan. 13, 2020 -
FDA OKs Abbott clinical trial of MitraClip in moderate risk patients
The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery.
By David Lim • Jan. 13, 2020 -
Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound
FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.
By David Lim • Jan. 10, 2020 -
Intuitive closes 2019 by topping Q4 expectations
Intuitive's 19% procedure growth helped it increase sales by 22%, according to preliminary results. But Medtronic, J&J and CMR Surgical are among the competitors that will press for share in the next few years.
By Nick Paul Taylor • Jan. 10, 2020 -
JenaValve TAVR tech amid wave to get breakthrough device status from FDA
Other devices recently designated include 3Derm Systems' AI to detect skin cancers, KDx Diagnostics' urine-based bladder cancer test, and Reflow Medical's retrievable stent for use in below-the-knee peripheral artery disease.
By Nick Paul Taylor • Jan. 10, 2020 -
Medtronic buys new spinal cord tech to boost pain therapies unit
Amid a broader slowdown in the spinal cord stimulation market, Medtronic is acquiring technology from Stimgenics that offers a new way of programming its Intellis implant.
By Maria Rachal • Jan. 09, 2020 -
Study links paclitaxel devices to better survival in PAD, muddying debate
New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.
By David Lim • Jan. 09, 2020 -
MedTech Europe pushes urgent action to keep devices on sale after MDR
The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.
By Nick Paul Taylor • Jan. 09, 2020 -
Abbott sets CFO transition in motion
The company plans to install a new chief financial officer a month before incoming CEO Robert Ford takes the helm.
By Maria Rachal • Jan. 08, 2020 -
FDA OKs alternative to open heart surgery for Abbott's HeartMate 3 pump
The less invasive procedure allows the left ventricular assist device to be implanted via an incision between the patient's ribs, an approval Medtronic received for its HeartWare product in 2018.
By Susan Kelly • Jan. 08, 2020
