7 medtech stories we missed this week: June 2, 2017

June 2, 2017 By Danielle Kirsh Leave a Comment

[Photo from unsplash.com]

From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. Dextera seeks expanded indications for MicroCutter 5/80 stapler

Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatric surgical procedures. It is also used for transection, resection and creation of anastomoses in the small and large intestines and for the transection of the appendix.

2. EndoGastric Solutions launches new EsophyX Z GERD device

EndoGastric Solutions has launched its EsophyX Z device outside of the U.S., according to a June 1 press release. The Esophy X Z device is used in the transoral incisionless fundoplication 2.0 procedure and is the 3rd generation of EsophyX devices from EndoGastric Solutions.

3. Inolife, eyeing up-listing, taps investment bank

Inolife Technologies announced in a June 1 press release that it has signed an agreement with Maxim Group to receive strategic corporate planning and investment banking services. Maxim Group will also help Inolife Technologies become fully reporting under SEC guidelines and hopes to finish an uplisting to the Nasdaq Capital Market within the next year.

4. Implandata wins CE Mark for Eyemate

Implandata received CE certification for its Eyemate system, according to a May 31 press release. The Eyemate system is used for enhanced monitoring and care of glaucoma patients. The Eyemate system uses a permanent implantable micro-sensor more directly measure eye pressure. A hand-held device powers sensors and reads data to communicate real-time through the Internet with eyecare doctors. The system received CE mark for use with primary open angle glaucoma patients.

5. MicroTransponder touts neurostim data

MicroTransponder announced in a May 30 press release that it had positive results Vivistim Stroke Rehabilitation clinical trial. The purpose of the trial was to improve upper limb mobility in stroke survivors who were suffering chronic disability. The data showed that 75% of patients had a clinically meaningful response on the Fugl-Meyer Upper Extremity Scale by the end of physical therapy after 6 weeks compared to 33% for the control group.

6. C2 Therapeutics touts cryoballoon data in Barret’s esophagus

C2 Therapeutics is touting data from its C2 CryoBalloon Ablation System clinical trial, according to a May 9 press release. The C2 CryoBalloon Ablation System is used for ablation of Barrett’s esophagus. The study suggested physicians had a shorter learning curve with CbAS than for radiofrequency ablation therapy and patients had less pain 2 days post-procedure than with RFA. It also showed that the ablation system had potential for CbAS in ablation of gastric antral vascular ectasia and esophageal squamous cell neoplasia.

7. DreaMed Diabetes, Harvard & Schneider Children’s Hospital to study Type I diabetes

DreaMed Diabetes, Harvard and Schneider Children’s Hospital announced in a May 9 press release that they have collaborated in an effort to improve insulin management for people who have Type 1 diabetes. The group plans to optimize therapy options for Type 1 diabetics who have multiple daily injections of insulin and use point-of-care capillary glucose measurements.

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… […]