Senseonics (NYSE:SENS) recently announced that the U.S. FDA has approved using the Eversense implantable continuous glucose monitoring (CGM) system as a replacement for fingersticks. Officials at the Germantown, Md.–based medical device company described the FDA approval for the non-adjunctive indication (dosing claim) as a major milestone. The company will make a new app available in coming months […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
Plaintiffs appeal Ocular Therapeutix win in shareholder lawsuit
Ocular Therapeutix (NSDQ:OCUL) is facing a revived class-action lawsuit lodged by investors after its share price took a hit after it revealed problems with its Dextenza device. The lawsuit, filed in the U.S. District Court for Massachusetts in November 2017, alleged that the Bedford, Mass.-based company misled shareholders about problems found by FDA inspections in 2017 […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
FDA warns against using ‘hacked’ diabetes devices
The FDA is warning the public against using unauthorized devices for diabetes management. After a report of a serious adverse event from a patient using an unauthorized device, the FDA is concerned about hacked devices used alone or with other authorized devices. In the report, a patient used an unauthorized device that received an electronic […]
Louisiana prisoners may get non-FDA-approved naltrexone implant
This article has been updated to clarify the BioCorRx’s role in the program. The Louisiana Department of Corrections is working with BioCorRx (OTC:BICX) to offer soon-to-be-released inmates an opioid addiction treatment implant that has not been approved by the FDA. The implant, which contains a compounded form of naltrexone, is one of several medication-assisted options being […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
FDA delays safety data reporting deadline for combination products
The FDA last month gave companies that make combination products an extra year to submit safety data to the federal safety watchdog. The new guidelines call for firms making drug-device combinations to submit individual case reports to the FDA’s Adverse Events Reporting System and electronic Medical Device Reporting system by July 31, 2020. Vaccine adverse […]
Phillips-Medisize Arkansas plant expands medtech capacity
Phillips-Medisize said today that it now has FDA-compliant manufacturing space in the Little Rock, Ark. plant of its parent company, Molex. The 380,000-square-foot facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations (21 CFR part 820) enforced by the FDA. The plant can now be used for Phillips-Medisize’s medical manufacturing services, including […]
Orchestra BioMed receives FDA Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon
Orchestra BioMed recently announced that its Virtue Sirolimus-Eluting Balloon has received Breakthrough Device destination from the FDA. The Breakthrough Designation is granted to medical devices and device-led combination products that can provide a more effective treatment of life-threatening or other debilitating diseases. It allows for medical devices to be expedited in their development, assessment and […]
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