MRI screening linked to improved detection of breast cancer

The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.

By Nick Paul Taylor • Dec. 2, 2019

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.

By Maria Rachal • Nov. 18, 2019

J&J reports rising success rate in robotic surgery clinical trial

The study is assessing diagnostic abilities of the Monarch robotic surgery platform, which Johnson & Johnson gained in the $3.4 billion acquisition of Auris Health.

By Nick Paul Taylor • Oct. 24, 2019

Experimental cancer IVD trial guidance finalized

AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.

By Nick Paul Taylor • Oct. 10, 2019

Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down

The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.

By Maria Rachal • Oct. 7, 2019

Edwards shows improved quality of life, durability of TAVR systems in trio of studies

Among other data presented over the weekend at TCT, Boston Scientific's in-development Acurate Neo TAVR system failed to meet a non-inferiority goal on safety and efficacy when compared to Edwards' Sapien 3.

By Susan Kelly • Sept. 30, 2019

Abbott's MitraClip outperforms medical therapy in study at 3 years

In addition, a group of patients that began the study on medical therapy and crossed over to the MitraClip at two years saw benefits matching those who received the device from the start.

By Susan Kelly • Sept. 30, 2019

Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy

The clinical trials provide data supporting the use of shorter regimens in coronary stent patients.

By Nick Paul Taylor • Sept. 27, 2019

Boston Scientific and Medtronic devices match on safety in 3-year TAVR trial

The Boston Scientific-backed trial found a similar rate of all-cause mortality between the two systems. Boston's device beat Medtronic's on rate of disabling stroke, but had more patients receiving a new pacemaker.

By Nick Paul Taylor • Sept. 26, 2019

FDA tries to spur patient shaping of clinical trial design with draft guidance

"Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate," acting FDA Commissioner Ned Sharpless said in a statement.

By Nick Paul Taylor • Sept. 24, 2019

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