FDA clears Gelesis weight-loss hydrogel pill Plenity
[Image from Gelesis]Gelesis (Boston) recently announced that it has received FDA clearance for its Plenity weight management prescription drug.
The drug is a weight management aid for adults who have a body mass index of 25-40 kg/m2 and is supposed to be used with diet and exercise. It can be used in people with and without comorbidities like hypertension, type 2 diabetes or dyslipidemia. The company says that there is no restriction on how long the drug can be used in weight management.
“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring th...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Pharmaceuticals Regulatory/Compliance Weight loss Gelesis Inc. Source Type: news
U.K. government requests Brexit deadline extension
By Ronald Boumans, Emergo Group
The U.K. government has requested a further delay in implementing its withdrawal from the European Union, with an April 12 deadline for a no-deal Brexit outcome fast approaching.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. (Source: Mass Device)
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
EO plant shutdown leads to pediatric breathing tube shortage
Smiths Medical Bivona tracheostomy tubes are in short supply, according to the FDA. (Image from Smiths Medical)
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA.
The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to a statement from Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH). The state of Illinois ordered t...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Food & Drug Administration (FDA) Hospital Care News Well Pediatrics Respiratory Sterilization / Calibration Center for Devices and Radiological Health (CDRH) Smiths Medical Sterigenics Internatio Source Type: news
NuVasive launches X360 lateral single-position surgery device
NuVasive Inc. (NSDQ:NUVA) said yesterday that it launched its X360 system intended for lateral single-position surgery in the U.S.
The newly launched X360 system features improvements intended to accommodate advanced techniques and technologies for enhanced operating room workflow and efficiency, the San Diego-based company said.
The system also features integration with NuVasive’s Pulse surgical automation platform to allow surgeons to perform multiple procedures from the lateral position.
“X360 has transformed my approach to treating patients, allowing me to customize my surgical workflow, reduce patient ane...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Surgical Nuvasive Source Type: news
Stryker wins FDA PMA, launches Lifepak CR2 AED
Stryker (NYSE:SYK) said yesterday that it launched its Lifepak CR2 defibrillator featuring the LifelinkCentral AED program manager after winning FDA premarket approval for the system.
The newly launched Lifepak CR2 AED features new technology including CPRInsight, which allows users to continue chest compressions during ECG analysis and can improve survival outcomes, the Kalamazoo, Mich.-based company said.
The Lifepak CR2 AED also features a child mode button to reduce defibrillation energy for pediatric patients and an optional bilingual feature.
The system can be connected to the LifelinkCentral AED program manager to ...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Stryker Source Type: news
TissueTech raises $55m
TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing.
The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business).
Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing.
The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, a...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Regenerative Medicine Wall Street Beat Tissuetech Source Type: news
FDA clears moldable OssiMend bioactive bone graft from Collagen Matrix
Collagen Matrix said today that it won FDA 510(k) clearance for its line of OssiMend Bioactive Moldable bone graft matrix products, intended for use in spinal procedures.
The Oakland, N.J.-based company said that the newly cleared OssiMend product is composed of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen, and that it can be molded into putty for filling irregular defect sites.
The moldable Ossimend product is designed to be slowly resorbed and replaced by new bone tissue, and comes in various sizes, Collagen Matrix said.
“We continue to expand our product portfo...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal collagenmatrix Source Type: news
Philips to private-label Demant hearing aids
William Demant (CPH:WDH) said this week that it inked a deal to market its line of hearing aid devices under Royal Philips (NYSE:PHG) brand.
Denmark-based Demant said that Amsterdam-based Philips will offer a complete range of hearing aids, accessories and applications under the Philips HearLink brand
“Based on a shared vision of improving the lives of people through innovative healthcare this new cooperation will not only change the way we see hearing healthcare, but also widen the definition of hearing healthcare, supporting healthier lifestyles and active aging. Combining Demant’s world-leading hearing aid te...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Otolaryngology Ear, Nose & Throat Royal Philips William Demant Holding Source Type: news
Ajax Health raises $85m for medtech investment
Ajax Health, the company formed in 2017 by a pair of private equity giants to manage their medical device investments, said today that it has raised more than $85 million to help fund operations and expansions of select medical device companies.
The round was led by HealthQuest Capital and joined by Aisling Capital and Polaris Partners, the Menlo Park, Calif.-based company said.
“Ajax Health approaches medical device innovation in a novel way, applying best-in-class strategies to pinpoint technologies with the greatest opportunity to take off, then rapidly developing them into a fully integrated business. Ajax Health...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat ajaxhealth Source Type: news
FDA: Duodenoscope reprocessing is dirtier than we thought
The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear.
Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the sco...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Featured Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Hoya Corp. Olympus Pentax Source Type: news
Synaptive Medical raises $5m
Synaptive Medical has raised approximately $5 million in a new round of debt and options financing, according to a recently posted SEC filing.
The Toronto-based company has not yet stated how it plans to spend funds raised in the round.
Synaptive Medical produces medical devices intended to facilitate surgical planning, navigation, robotic automation, digital microscopy and informatics through an interconnected platform, according to its website.
Money in the round came from a single unnamed investor, according to the filing, with the first date of sale noted as having occurred on March 26.
Last month, Synaptive Medical s...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Synaptive Medical Source Type: news
Ex-MiMedx CEO Petit mounts proxy war
MiMedx (NSDQ:MDXG) is facing a proxy battle being led by former CEO Parker Petit, who was ousted last July “for cause”, according to a recently posted SEC filing.
The ex chief-exec nominated himself alongside former Pulte Home Corp tax director David Furstenburger and George & Lorenson partner Shawn George as candidates for the company’s board of directors, set to be elected at an upcoming shareholder’s meeting.
Petit said that he believes that the current MiMedx board has “failed shareholders with disappointing performance, failure to ensure competent leadership and lack of engagement wi...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Wall Street Beat MiMedx Group Inc. Source Type: news
Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case
A state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products.
Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the ...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Product Liability Wall Street Beat Ethicon johnsonandjohnson Pelvic Mesh Lawsuits Source Type: news
Align Technology puts $31m price tag on forced retail store closures
Align Technology (NSDQ:ALGN) yesterday put a price tag of as much as $31 million on the forced closure of its Invisalign retail outlets after losing arbitration with SmileDirectClub last month.
The March 4 decision required San Jose, Calif.-based Align Technology to close the stores by April 3 and enjoined it from opening new Invisalign stores or providing clear aligner devices in brick-and-mortar stores.
First piloted in 2017, the number of Invisalign stores had risen to 12 by last year. Yesterday the company said it expects the closures to result in first-quarter charges of between $26 million and $31 million, including...
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Dental Featured Wall Street Beat aligntechnology Source Type: news
Canadian regulators clarify changes in qualifications for medical device licenses following Sterigenics shutdown
By Stewart Eisenhart, Emergo Group
Canadian medical device regulator Health Canada has issued a clarification on which changes to Medical Device License (MDL) holders’ sterilization processes constitute “significant changes” following the closure of a major sterilization facility in the US earlier in 2019.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees. (Source: Mass Device)
Source: Mass Device - April 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog Emergo Group Source Type: news
