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.

Mojo Vision developing ‘smart’ contact lens
Mojo Vision is working with the FDA to develop a smart contact lens to help people with low vision. The lens overlays real-time contrast and lighting enhancements with zoom functionality and recently won FDA breakthrough device designation. “Receiving the Breakthrough Device Designation is a significant step in our research and development process. We look forward to… […]
FDA to EPA: Leave us out of your ethylene oxide rule
This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical… […]
Clippart debuts stepper-controlled flow valve
Clippard recently launched a new stepper-controlled proportional valve for precision flow control. The Eclipse valve uses the industry’s most robust and powerful miniature linear actuator, according to Cincinnati-based Clippard. The patent-pending Eclipse is designed for liquid and gas delivery, medical, analytical and industrial automation requiring ultra-fine resolution and repeatability. The design also allows for custom… […]
Supporting regulatory affairs departments to address clinical requirements under new MDR
By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog… […]
5 tips to raise funding for your medical device
Securing funding can be a long and tedious process, and medical device businesses must work to position themselves as especially attractive to potential investors to maximize success and accelerate the fundraising process. Jon Speer, Greenlight Guru According to Alejandro Cremades, author of The Art of Startup Fundraising, it can take from six to nine months… […]
FDA recognizes latest ISO 14971 as medical device consensus standard
By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are… […]
Synaptive Medical updates Modus V surgical microscope
Synaptive Medical announced that its U.S. and Canadian Modus V robotic digital microscope now includes updates such as additional 3D visualization and voice-activated control. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex cranial procedures. The Modus V provides similar… […]
New machine can preserve donor livers for 1 week
Researchers in Switzerland have built a perfusion machine that can preserve human livers for transplantation for a week or more, potentially slashing the number of donor livers that must be discarded due to time-related deterioration. Existing perfusion technology can preserve a donor liver for up to 24 hours. The team of surgeons, biologists and engineers… […]
Smiths Medical launches Portex tracheostomy tubes and kits
Smiths Medical this week launched its Portex polyvinyl chloride tracheostomy tube and kit portfolio. The new polyvinyl chloride (PVC) tube portfolio has options for a variety of patients, according to the company. “Our goal was to create tracheostomy tubes and kits designed to help clinicians provide the best patient care. We’re excited to offer a variety… […]
FDA clears Cleveland Clinic 3D-printed airway stents
The FDA recently cleared 3D-printed, patient-specific stents developed by a doctor at the Cleveland Clinic. Cleveland Clinic physician Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses. Airway stents come in a limited number of sizes and shapes and are… […]
Boston Scientific shares drop on Q4 sales news
Shares in Boston Scientific (NYSE:BSX) dropped 8% this morning on news of disappointing fourth-quarter sales. The company’s preliminary earnings report showed sales for the quarter ended Dec. 31, 2019 coming in at $2.9 billion, below the $2.91 billion that analysts were expecting. The unaudited sales figure represents organic growth of 7.3%, missing the company’s own guidance of… […]