7 medtech stories we missed this week: April 14, 2017

April 14, 2017 By Danielle Kirsh Leave a Comment

[Image from unsplash.com]

From FDA approvals to business expansion plans, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. BioTelemetry launches offer to acquire LifeWatch

BioTelemetry and LifeWatch announced in an April 9 press release that the 2 companies have entered a transaction agreement that states BioTelemetry will launch a tender offer to acquire all shares of LifeWatch. The LifeWatch shareholders will receive either 10 Swiss francs in cash and 0.1457 shares of BioTelemetry stock per LifeWatch share or 8 Swiss francs in cash and 0.2175 shares of BioTelemetry stock per LifeWatch share. The deal is expected to be worth approximately 260 million Swiss francs.

2. FDA approves marketing of first whole slide imaging system for digital pathology

The FDA approved marketing for the Philips IntelliSite Pathology Solution (PIPS), according to an April 12 press release. PIPS is the first whole slide imaging system that allows for review and interpretation of digital surgical pathology slides that are prepared from biopsied tissue. The FDA has not permitted the marketing of a whole slide imaging system for these purposes before. PIPS uses hardware and software to scan and digitize conventional surgical pathology glass slides that have been prepared from biopsied tissue at 400x magnification resolutions. Pathologists can review and interpret those images.

3. Second Sight touts first Asian Argus II implantation

Second Sight Medical Products announced in an April 13 press release that it has implanted its Argus II implants into its first patients in Asia through an exclusive distribution partnership with Orient Europharma. The Argus II system provides electrical stimulation that can bypass the defunct retinal cells and stimulates remaining viable cells. The procedure induces visual perception in individuals with severe to profound retinitis pigmentosa.

4. Acelity enhances VAC Ulta therapy system

Acelity has announced 2 significant enhancements to its VAC Ulta therapy system, according to an April 13 press release. The negative pressure wound therapy system has been enhanced to improve clinicians’ experiences by using first-to-market connectivity technology, iOn Results remote therapy monitoring. It connects hospitals to Acelity’s service and support offering to promote compliance and drive proper patient utilization of therapy. The VAC Ulta 4 therapy system has simplified functionality, reports summative therapy and allows for on-screen selection of 4 therapies on a device. The enhancements in the technology provide better accuracy and certainty for clinicians to improve outcomes for patients at a lower cost, according to Acelity.

5. Health Canada approves Sight Science’s Visco 360

Sight Science announced in an April 13 press release that its Visco 360 viscosurgical system has been approved by Health Canada. The Visco 360 system is used for the microcatheterization and transluminal viscodilation of the Schlemm’s canal to reduce intraocular pressure in adults with open-angle glaucoma. The Visco 360 viscosurgical system gives ophthalmologists a user-friendly, clear corneal approach to canaloplasty.

6. Toshiba Medical launches Aquilion Lighting CT

Toshiba Medical has officially launched its Aquilion Lightning 80 CT system, according to an April 11 press release. The 80-detector row system is designed for full body imaging and routine scanning. With CT technology found in high-end systems, it has fast reconstruction speeds at a full resolution of up to 50 images per second and the industry’s thinnest slices at 0.5 mm and a 78 cm bore.

7. CollPlant touts post-market surveillance study data

CollPlant announced in an April 11 press release that it has released the data from its European post-marketing surveillance of its wound care product, Vergenix FG, that is intended to treat patients with chronic and hard-to-heal wounds. CollPlant monitored 10 patients who underwent one treatment of Vergenix FG. Five weeks after treatment, patients showed an average wound closure of 80% and had no safety or tolerability issues.

Here’s what we missed last week.

Medline reopens Illinois medtech sterilization plant
Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize… […]
DeviceTalks Weekly Podcast: Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less than… […]
AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech… […]
March 2020 Issue: Is software key to medical 3D printing innovation?
What’s the word on ethylene oxide? The coronavirus pandemic has pushed a lot of news out of people’s minds, but medtech has other big issues to deal with. For instance, 8 months have passed since the FDA issued a public challenge for alternatives to ethylene oxide (EtO) as a sterilant for medical devices. As I… […]
GE Healthcare quadruples ventilator production at Wisconsin plant
General Electric Healthcare (NYSE:GE) this week announced that it is doubling its production capacity for ventilators and expanding its Madison, Wisconsin, production line to 24-hour operation. In a report on GE’s website, the company shared that it has doubled its capacity of ventilator production with plans to double it again by the end of the second… […]
FDA issues FAQ on 3D-printed equipment against coronavirus
Intrepid 3D printing companies and individuals who want to print masks, gowns and other personal protective equipment (PPE) to fight the coronavirus pandemic might want to take a look at the FDA’s new frequently asked questions page on the topic. While it says it welcomes coronavirus-fighting efforts, the agency said that 3D-printed masks are unlikely… […]
Software is enabling medical 3D printing innovation: Here’s how
The 3D printers themselves get a lot of attention, but for 3D-printing to become ubiquitous in the medtech space, software will have to play a key role. A 3D printer without software to tell it where to place the material is a really nice, expensive coffee table, according to Scott Rader, a former Stratasys GM… […]
This open source ventilator hackathon could help fight the coronavirus
Infineon engineers developed a 3D printed lung ventilator to help address the shortage of ventilators due to the COVID-19 pandemic. The German federal government held a hackathon called #WirvsVirus (“We against the virus”) where 42,000 people met to find solutions to challenges from the coronavirus. Infineon engineers, led by Mahmoud Ismail who has a doctorate… […]
Could these DIY ventilators stop coronavirus from killing people?
Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory effects of… […]
DIY ventilators? Not unless there’s a zombie apocalypse.
News reports of the COVID-19 virus have given a lot of space to the shortage of respiratory ventilators. The Society of Critical Care Medicine claims at least 950,000 U.S. patients could need ventilators but hospitals only have 160,000. One response to statistics like these has been a movement among open-source promoters to initiate community-designed ventilators… […]
FDA announces EUAs related to ventilators to treat coronavirus
Amid a shortage of ventilators for treating coronavirus, the FDA put out a statement confirming its stance on issuing emergency use authorizations for potential temporary fixes. The FDA said it is operating on the basis of a EUA determination that the U.S. Dept. of Health and Human Services issues on Feb. 4. Earlier this week, HHS declared… […]