Adaptive lands deal to provide NGS-based cancer tests to Amgen

The giant biotech will pay annual development fees, sequencing payments and regulatory milestones that could amount to a notable source of revenue for Adaptive.

By Nick Paul Taylor • Sept. 19, 2019

Mesh as good as hysterectomy for prolapse, 3-year NIH data suggests

The latest clinical trial outcomes appear in JAMA five months after FDA said mesh manufacturers had failed to prove adequate safety and effectiveness of the devices in patients with pelvic organ prolapse.

By Maria Rachal • Sept. 18, 2019

Apple to start trio of research studies on hearing, heart and women's health

The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.

By David Lim • Sept. 11, 2019

Physicians push FDA to shed light on device comparators

In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.

By Nick Paul Taylor • Sept. 11, 2019

Medtronic touts new data on DCB in dialysis patients

The IN.PACT drug coated balloon received an expanded CE mark indication in January 2016 to treat AV access for patients with end-stage renal disease.

By David Lim • Sept. 9, 2019

Racing Edwards, Abbott starts pivotal trial of tricuspid device

The product, a sibling of MitraClip, could become the first transcatheter tricuspid device of its kind on the U.S. market.

By Nick Paul Taylor • Sept. 6, 2019

Biotronik's Orsiro stent beats Abbott's Xience in head-to-head trial

The trial linked the "ultrathin" Orsiro to a lower rate of target lesion revascularization than Abbott's incumbent device.

By Nick Paul Taylor • Sept. 4, 2019

FDA urges providers, manufacturers to transition to duodenoscopes with disposable parts

Boston Scientific told investors last year single-use duodenoscopes represent a market opportunity of more than $1 billion dollars.

By David Lim • Aug. 30, 2019

Surmodics passes milestone in trial of Abbott-licensed paclitaxel-coated balloon

Surmodics completed enrollment sooner than some analysts expected on a trial comparing its paclitaxel-coated balloon to Medtronic's IN.PACT Admiral.

By Nick Paul Taylor • Aug. 29, 2019

Titan Medical delays 510(k) submission until 2020 amid cash burn concerns

The company plans to use the delay to spread out its spending while working to implement the robotic surgery system's sterile instrument interface components, software improvements and training tools.

By David Lim • Aug. 27, 2019

Big data, cybersecurity among top FDA device center priorities

Reprocessing of devices and biocompatibility are also addressed in a report intended to incorporate new tech into regulatory decisions.

By David Lim • Aug. 23, 2019

ViewRay touts promising early results from localized prostate cancer trial after disappointing quarter

Weeks after cutting revenue targets for 2019, the company reported low incidence of early gastrointestinal and genitourinary toxicity in patients who received the magnetic resonance-guided radiation therapy.

By Maria Rachal • Aug. 21, 2019

FDA approves MRI labeling for Boston Scientific DBS system

CEO Michael Mahoney touted the growth of the company's deep brain stimulation products to investors during its second quarter earnings call.

By David Lim • Aug. 20, 2019

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

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

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

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