Materialise said today it won FDA 510(k) clearance for its Mimics inPrint software designed for 3D printing anatomical models for diagnostic use, touting it as the first clearance of its kind. The Belgian company said that last August, the FDA ruled that software designed to create files for 3D printing patient-specific anatomical models for diagnostic purposes […]
Diagnostics
This new technology could help surgeons clear out leftover cancer cells
In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew Claney] After his wife died of breast cancer in 2003, David Lee stepped away from […]
BD finds chemical from blood collection tube interferes with Magellen lead test
Studies conducted by Becton Dickinson (NYSE: BDX) found that a chemical present in its Vacutainer blood collection tubes interfered with lead tests made by Magellan Diagnostics. The FDA first warned consumers in May of 2017 that Magellan’s lead tests may provide inaccurate results when used with blood drawn from the vein and held in BD’s blood collection […]
Alere forks over $33m to settle DOJ inquiry
The U.S. Dept. of Justice said today that Abbott‘s (NYSE:ABT) Alere (NYSE:ALR) agreed to pay $33.2 million to resolve allegations that it knowingly sold unreliable point-of-care diagnostic devices, causing hospitals to submit false claim to Medicare, Medicaid and other federal healthcare programs. The U.S. alleged that Alere sold materially unreliable Triage devices, which are designed to diagnose serious […]
10 women medtech leaders you should know
There is a women’s leadership gap in the U.S., and women in medtech have been working to alleviate that problem. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S., but only 14.6% are CEOs, 8.1% are top earners and 4.6% are Fortune 500 CEOs. More specifically, […]
UroViu wins FDA nod for disposable diagnostic cytoscope
UroViu said yesterday it won FDA 510(k) clearance for its Uro-V single-use diagnostic cytoscopic system designed to visually assess the urethra and urinary bladder in instances of suspected pathology or dysfunction. The Bellevue, Wash.-based company’s newly cleared Uro-V device is a self-contained single-use diagnostic cytoscope designed for female diagnostic cytoscopy. The system is designed to […]
7 medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
Study: Wearable AI-powered biosensors show promise for HF detection
Wearable biosenors with artificial intelligence-based analytics can provide accurate early detection of impending rehospitalization similar to implanted devices, according to data from a new study backed by the US Dept. of Veterans Affairs. The trial explored the ability of wearable sensors, developed by VitalConnect, supported by AI-driven analytics, developed by PhysIQ, to effectively predict heart […]
8 women medtech innovators you need to know
As we celebrate more women becoming medtech leaders and paving the way for innovation, it’s important to remember the many accomplishments women have already made when it comes to the advancement of health and medicine. X-rays on the battlefield, the American Red Cross, leprosy treatment and more — these advances happened because of women. As […]
SEC charges Theranos, CEO Holmes with ‘Massive Fraud’
The US Securities and Exchange Commission today charged controversial blood-testing developer Theranos, founder & CEO Elizabeth Holmes and former prez Ramesh Balwani with “massive fraud” – charges which Theranos and Holmes have agreed to resolve, according to the SEC. Charges include claims that the company raised more than $700 million from investors in “an elaborate, […]
Drug delivering contact lenses win MIT’s top healthcare innovation prize
Contact lenses that deliver medications directly to the eye over a period of days or weeks was the recent grand prize winner of Massachusetts Institute of Technology’s Sloan Healthcare Innovation Prize. The MIT Sloan Healthcare Innovation Prize competition had 8 finalists who pitched their healthcare innovations to judges from Optum and other local venture firms, […]