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

Imaging study links poorly controlled blood pressure to marker of cognitive decline

A NIH-funded imaging trial found intensive blood pressure treatment tied to reductions in lesions associated with cognitive decline.

By Nick Paul Taylor • Aug. 14, 2019

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

FDA to update paclitaxel device labels with mortality signal warning

The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.

By David Lim • Updated Aug. 8, 2019

Titan Medical warns robotic surgery filing target may slip

The Canadian medtech called the regulatory filing schedule "very tight" and "not completely within [its] control."

By Nick Paul Taylor • July 24, 2019

CVS launches home hemodialysis device clinical trial

The drugstore giant, which now includes insurance heavyweight Aetna, argues it can help reduce the $35 billion in Medicare costs associated with the treatment of end-stage renal disease.

By David Lim • July 17, 2019

FDA finalizes IDE broadcasting guidance, with concessions to industry

The final text is a major rewrite of a 2014 draft, which was criticized by AdvaMed.

By Nick Paul Taylor • July 11, 2019

Medtronic HVAD shows low stroke risk in study of thoracotomy approach

The clinical data could help Medtronic reverse market share losses to Abbott, which makes a competing left ventricular assist device for patients suffering from advanced heart failure.

By Susan Kelly • July 9, 2019

FDA offers guidance on data for prostate ablation devices

The document addresses clinical studies for general surgical tools for prostate tissue ablation, differentiating them from technologies treating specific diseases like prostate cancer or benign prostatic hyperplasia.

By Susan Kelly • June 26, 2019

Label should warn patients of paclitaxel device mortality signal, FDA panel says

The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.

By David Lim • June 21, 2019

As CMS decision on TAVR looms, a push for broader access

Proposed agency rules would lower the bar for hospitals performing the less invasive heart procedure, but would also raise the eligibility requirements to offer the treatment.

By Nick Paul Taylor • June 18, 2019

Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA

Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.

By Nick Paul Taylor • June 11, 2019

Device interoperability, CGM for Type 2 patients among ADA 2019 standouts

More options for automated insulin dosing systems are emerging, particularly as FDA established new device classifications for interoperable pumps and glycemic controller algorithms via the De Novo pathway.

By Maria Rachal • June 10, 2019

Abbott and Tandem in the spotlight at diabetes meeting

Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.

By Nick Paul Taylor • June 7, 2019

Philips' 3-year data links drug-coated balloon to sustained benefits

The company's low-dose paclitaxel-coated Stellarex beat or matched uncoated balloons on key endpoints, including rates of primary patency and mortality.

By Nick Paul Taylor • May 30, 2019

Edwards presents 6-month data on Pascal, eyeing MitraClip

The structural heart giant's CE-marked system showed sustained mitral regurgitation improvement in patients. The company is gearing up for a head-to-head trial against Abbott's device, which is the only FDA-approved option.

By Maria Rachal • May 23, 2019

FDA wants new companies to help test its Pre-Cert Program

One pilot company's CEO told MedTech Dive FDA's search for new companies "is not a surprise to us" and "is a really good thing for the Pre-Cert program."

By David Lim • May 23, 2019

Medtronic results build case for renal denervation device

One study linked Symplicity to a reduced occurrence of subclinical atrial fibrillation in a subset of high-risk patients.

By Nick Paul Taylor • May 23, 2019

Biotronik stent bests Medtronic in study of small-vessel lesions

Evidence from a sub-group analysis of a three-year clinical trial supports the theory that stents with very thin struts are less likely to require repeat revascularization in patients.

By Nick Paul Taylor • May 22, 2019

J&J's Auris unveils early results on Monarch robot for lung procedures

The FDA-cleared robotic platform successfully localized lung nodules in 92% of patients, Auris Health reported at the American Thoracic Society Conference.

By Susan Kelly • May 21, 2019

Titan Medical's losses balloon as robotic surgery R&D drive accelerates

The company plans to file for a CE mark and 510(k) clearance for its robotic surgery platform by the end of the fiscal year. It aims to start early U.S. commercialization in 2020.

By Nick Paul Taylor • May 16, 2019

Medtronic posts data on stent grafts and venous closure systems

The endosuture aneurysm repair and chronic venous disease data suggest the efficacy seen earlier in the studies is durable.

By Nick Paul Taylor • April 18, 2019

Pfizer, Concerto collaborate on AI in precision oncology

The agreement is Concerto's second AI collaboration with a big pharma company in recent weeks and will focus on identifying new treatment options, refining study designs and speeding completion times for outcome studies.

By Susan Kelly • April 10, 2019

TAVR called 'game changing' in studies of low-risk patients

Data from Edwards Lifesciences' Partner 3 trial and Medtronic's Evolut Low Risk study prompted predictions that TAVR will become the preferred option for a wider population of heart valve patients.

By Susan Kelly • March 18, 2019

Apple heart study: Early proof of concept, or a gimmick?

Doctors at the American College of Cardiology meeting said the Apple Watch's foray into health monitoring needs more data to prove its value. 

By David Lim • March 16, 2019

Apple, Medtronic and more medtech to track at ACC19

Anticipated data backing the tech giant's heart rhythm-tracking watch, results from Medtronic and Edwards aimed at broader use of TAVR procedures, and an update on Abbott's MitraClip highlight the annual conference.

By Maria Rachal • March 14, 2019