The Latest
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Wright Medical misses Q4 targets as Cartiva shortfall persists
In its annual report, the Stryker target said revenues from its 2018 acquisition of the synthetic cartilage implant maker totaled $25.7 million, compared to the $47 million it had hoped for at the start of the year.
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LivaNova gets nod for heater-cooler device changes to cut contamination risk
At the same time, FDA updated its safety guidance for healthcare providers to reduce infection risk during open heart surgery.
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Analysis casts doubt on Boston Scientific TAVR embolic protection device
The JAMA Internal Medicine research rekindles debate over whether the device, designed to catch dislodged plaque debris in the carotid arteries before it reaches the brain, is truly effective.
UPDATED: Feb. 25, 2020 at 3 p.m. -
Johnson & Johnson
Battle of the 'bots: 4 robotic surgery rivalries to watch in the year ahead
Two decades after FDA cleared Intuitive's da Vinci for general surgery, a crowded field of medtechs looks to expand the reach of robots in bronchoscopy, bariatric surgery, joint replacements and more.
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Guardant Health
Guardant predicts net loss doubling as it takes on Exact Sciences' Cologuard
The cancer testing company's CEO said new studies could open up significant market opportunities, justifying the spending surge.
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Tandem shapes FDA strategy for new insulin pump features
Fourth quarter revenues grew 42%, roughly in line with Wall Street's expectations. Shares were down 7% in late morning trading.
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AI clinical documentation player Nuance preps for nationwide expansion
The technology, built in partnership with Microsoft, includes a wall-mounted device with microphones and other multi-sensory capabilities to record patient interactions and upload them into the EHR.
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On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging
The agency scheduled an orthopaedic devices advisory panel for April to consider down-classing noninvasive bone growth stimulation systems. On Tuesday, a meeting on artificial intelligence in radiological imaging kicks off.
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Jacob Bell / BioPharma Dive
1st test for genetic condition tied to developmental delay wins FDA nod
Austin, Texas-based biotech Asuragen won De Novo authorization for a blood test for Fragile X Syndrome, which the agency said is the most common known cause of inherited developmental delay and intellectual disability.
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Adobe Stock
FDA taps breakthrough device meant to prevent opioid overdose deaths
A small Scottish medtech won the fast-track designation for a biosensor that identifies potentially fatal opioid-induced respiratory depression and notifies first responders to administer naloxone.
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CMS pitches expanding bundled payments for joint replacements
Regulators want to include outpatient hip and knee replacements now that the procedures are off the inpatient-only list. Post-acute care providers may face more financial risk than device makers, some analysts believe.
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Ortho, spine players Smith & Nephew, NuVasive and Globus post Q4 results
The three rivals posted healthy sales growth, with Smith & Nephew topping $5 billion in revenue for 2019.
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Adobe Stock
Dexcom makes inroad in pregnant population with CE mark for CGM
Real-world evidence and other research helped the company secure a CE mark, CEO Kevin Sayer told MedTech Dive on Thursday, calling it "a first step toward a very big market for us."
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Teleflex strikes $260M deal, gaining parts used in TAVR procedures
In releasing quarterly results, the Wayne, Pennsylvania-based medtech also gave updates on a new direct-to-consumer ad campaign and headwinds expected from the coronavirus outbreak.
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Jacob Bell
Cardiovalve gets FDA breakthrough status for tricuspid valve replacement system
The startup, spun out during Edwards' 2017 acquisition of Valtech Cardio, also received U.S. approval to run an early study of its transcatheter system targeting tricuspid regurgitation.
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Jacob Bell / BioPharma Dive
FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk
Problems with the affected coronary catheters from Abbott and ventilators from ResMed each resulted in one death, the agency reported Wednesday.
UPDATED: Feb. 20, 2020 at 1:12 p.m. -
Kendall Davis/MedTech Dive, original photos courtesy of Abbott and Dexcom
Abbott, Dexcom outline plans for CGM compatibility with Insulet's Horizon
As a key diabetes conference gets underway, the dominant glucose monitoring medtechs specified that G6, G7 and FreeStyle Libre 2 users will be able to integrate with the tubeless, smartphone-operated insulin delivery system.
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Fotolia
Private equity medical practice takeovers more than doubled from 2013 to 2016
Heart, eye and radiology medical practices were among the increasingly attractive targets, according to research published in JAMA.
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Fotolia
Senseonics' implantable CGM wins Cigna coverage, shares soar
The diabetes tech manufacturer's stock closed up 24% on the news. CEO Tim Goodnow late last year identified Cigna, along with Anthem and UnitedHealthcare, as key commercial payers to win over.
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DHS warns of WannaCry-like vulnerability in Spacelabs Healthcare systems
The homeland security agency revealed certain telemetry devices suffer from the weakness, scoring 9.8 out of 10 on a cybersecurity vulnerability scale.
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Medtronic misses revenue estimates as TAVR position falters
A disappointing quarter for the medtech giant, with particular softness across pain therapies and cardiac rhythm and heart failure, sent shares down nearly 4% in morning trading Tuesday.
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Fotolia
Most large hospitals embrace patient-facing digital tools despite cost concerns
A new survey from the Center for Connected Medicine found digital tools helped healthcare professionals manage simple tasks like accessing health records, making appointments and paying bills.
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As CMS coverage decision nears, Abbott gears for MitraClip expansion
An expanded national coverage determination could accelerate already-strong sales of the device, and the company is planning to add manufacturing capacity and sales reps in anticipation.
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Jacob Bell / BioPharma Dive
FDA tracks uptick in masks, other protective gear in coronavirus update
Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”
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Baxter closes $350M acquisition of Sanofi's Seprafilm adhesion barrier
The company said it will immediately begin integrating the product, meant to reduce adhesion barriers in patients having abdominal or pelvic laparotomy procedures, into its advanced surgery business.
UPDATED: Feb. 18, 2020 at 10:14 a.m.
