7 medtech stories we missed this week: Nov. 3, 2017

November 3, 2017 By Danielle Kirsh

[Image from unsplash.com]

From Hologic’s new product launch to CapsoVision gettting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Hologic launches new MyoSure device

Hologic announced in a Nov. 1 press release that it has launched its MyoSure Manual Device in the U.S. The device is designed to help doctors resect and remove intrauterine tissue easily in an office setting if used with the MyoSure hysteroscope.

2. IntraFuse wins FDA clearance for FlexThread fibula pin

IntraFuse has received FDA 510(k) clearance for its FlexThread Fibula Pin System, according to a Nov. 1 press release. The system is designed to help improve outcomes for orthopedic extremity procedures. It has a percutaneous fixation of distal fibula fractures like Danis-Weber B type fractures or trans-syndesmotic fractures.

3. Skyline Medical, Helomics ink personalized cancer care deal

Skyline Medical and Helomics have announced their collaboration in a Nov. 1 press release to develop new approaches for personalized cancer diagnosis and care using the Helomics D-CHIP. D-CHIP uses an artificial intelligence-powered bioinformatics engine to show insights from cancer patient data to help with disease diagnosis and develop new diagnostics and therapies.

4. Sensus Healthcare wins Mexico nod

Sensus Healthcare has been cleared to sell its SRT-100 in Mexico, according to an Oct. 31 press release. The system has been approved to treat non-melanoma skin cancer and keloids and is set to be placed on the National Registry by February 2018.

5. Vesalio wins CE Mark for NeVa thrombectomy device

Vesalio announced in an Oct. 31 press release that it has received CE Mark certification for its NeVa neurotheomectomy platform for treating strokes. The mechanical thrombectomy technology was designed to improve first pass success and capture and remove clots that can create sudden blockages in blood flow to the brain.

6. BRH Medical wins FDA nod

BRH Medical has received FDA 510(k) clearance for its BRH-A2 device that reduces pain and promotes healing of deep wounds, according to an Oct. 31 press release. The technology engages and stimulates the wounded area from below the wound bed using ultrasound and electric field modalities to affect the tissues and muscles in the region of and below the wound. It can be used with any treatment modally and is portable enough to be used in clinics and hospitals.

7. Capsovision gets CE Mark

Capsovision announced in an Oct. 25 press release that it has received CE Mark approval for its CapsoCam Plus System for patients who are age 2 and older. It is a wire-free capsule endoscopy system that gives physicians a full 360º panoramic lateral image of the small bowel mucosa.

Here’s what we missed last week.

CVRx CEO details the path from being engineer to medtech executive
Nadim Yared, CEO of CVRx[/caption] This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure. The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology. In… […]
What’s next for nitinol tubing?
Nitinol’s unique properties have made it the darling of the medical device industry. A novel technique for mechanically joining nitinol to other metal tubing could reduce cost and mitigate risk. Mark Broadley, Viant Nitinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for… […]
Report: Haemonetics’ blood-collection devices could leave particles in donors
A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare… […]
Spinal Elements’ cervical fixation system wins FDA nod
Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation. Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps… […]
How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
Switchback Medical adds ‘sandbox approach’ to device testing
Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
FDA gives certain device makers more time to add UDIs
The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
How is RF technology shaping the future of medtech?
RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]