J & J offers few details on headcount, HQ following $16.6B Abiomed acquisition
Johnson& Johnson Inc. is offering few details yet about the future of Abiomed's Massachusetts footprint once its acquisition of the medical device maker closes in early 2023. Here's what we know. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - November 1, 2022 Category: Health Management Authors: Rowan Walrath Source Type: news

FDA panel to examine evidence that pulse oximeters may not work as well on dark skin
A panel of the US Food and Drug Administration's Medical Devices Advisory Committee will meet Tuesday to review clinical data about the accuracy of pulse oximetry in patients with darker skin and to discuss recommendations on using these devices on people with dark skin tones and whether they should have labels noting that inaccurate readings may be associated with skin color. (Source: CNN.com - Health)
Source: CNN.com - Health - November 1, 2022 Category: Consumer Health News Source Type: news

Thermo Fisher to buy U.K. diagnostics firm for $2.6B
Coming off a strong third quarter, Waltham medical device giant Thermo Fisher Scientific Inc. is deploying some of its cash to buy a U.K. diagnostics firm. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - October 31, 2022 Category: Biotechnology Authors: Rowan Walrath Source Type: news

Lab Notes: Philadelphia region rises in ranking of life sciences clusters; Malvern medical device maker raises $1.8M
This week's Lab Notes has details on where Philadelphia places in a national ranking of life sciences hubs, a medical device company's latest financing, a major health insurer and lab services provider extending their partnership, and more. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 28, 2022 Category: American Health Authors: John George Source Type: news

Q & A: Why medical device company Penumbra is betting on VR
Adam Elsesser, president, chairman and CEO of Penumbra, describes the medical device company ' s move into virtual reality and how its REAL system helps therapists measure a patient ' s progress.     (Source: mobihealthnews)
Source: mobihealthnews - October 28, 2022 Category: Information Technology Source Type: news

Tigard Woman Sentenced for Failing to Register as a Distributor of Foreign-Sourced Medical Devices
FDA OCI, Yasemin Zafar, Tigard, Oregon, sentence, guilty plea, failure, register, HHS, distributor, Hyaluronic acid, injectables, Korea, online, purchase, filler, cheek, augmentation, FDA, regulatory authority, consumer protection, (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - October 28, 2022 Category: Medical Law Authors: DOJ Source Type: news

Boulder-based medical device company secures $1M investment
The company developed a surgical system to help people with breathing abnormalities and is on its way to opening for business. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 28, 2022 Category: American Health Authors: Analisa Romano Source Type: news

Roundup: Singular Health gets 510(k) for 3Dicom MD and more briefs
Also, Cabrini Technology is adding medical device cybersecurity to its service offerings. (Source: mobihealthnews)
Source: mobihealthnews - October 28, 2022 Category: Information Technology Source Type: news

Levison Enterprises Expands Capabilities With ISO 13485 Certification
FDA-registered medical device manufacturer, Levison Enterprises has been certified to ISO 13485.(PRWeb October 28, 2022)Read the full story at https://www.prweb.com/releases/2022/10/prweb18978265.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - October 28, 2022 Category: Pharmaceuticals Source Type: news

Hindustan Syringes & Medical Devices reduces syringe production as demand for vaccination drops
Rajiv Nath, managing director, HMD, told ET that the government has either suspended the orders or rescheduled it to next year. (Source: The Economic Times)
Source: The Economic Times - October 28, 2022 Category: Consumer Health News Source Type: news

Woman Sentenced to Probation for Offering Illegal Silicone Augmentation Injections
FDA OCI, Debra Esteves-Mel éndez, sentence, probation, fine, illegal, buttock, injections, Belleza Vital Spa, Belleza Vital Estetic, BVE, Caguas, Puerto Rico, Colombia, polydimethylsiloxane, silicone oil, FDA, medical device, health care fraud, (Source: Office of Criminal Investigations (OCI) Press Releases)
Source: Office of Criminal Investigations (OCI) Press Releases - October 27, 2022 Category: Medical Law Authors: DOJ Source Type: news

Qnovia aims to bring smoking cessation medical device to market in 2025
Fresh off a $17 million Series A round, Qnovia is looking to bring a smoking cessation medical device to market in 2025. Health care executive Mario Danek founded the company in 2018. The goal is to develop and market RespiRx, a hand-held aerosol device that delivers nicotine quickly, helping people quit smoking. In 2020, Brian Quigley, the former CEO of Altria Group ’s smokeless division, joined the company as COO. He was named CEO in August, and Danek moved over to chief technology officer.… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - October 26, 2022 Category: American Health Authors: James Shea Source Type: news

Sleep Apnea Device Recall Drags on, Stoking Frustration
WASHINGTON — A massive recall of millions of sleep apnea machines has stoked anger and frustration among patients, and U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year. Sound-dampening foam in the pressurized breathing machines can break down over time, leading users to potentially inhale tiny black particles or hazardous chemicals while they sleep, manufacturer Philips warned in June 2021. Philips initially estimated it could repair or replace the units within a year. But with the recall expanding to more than 5 million devices worldwide, the Dut...
Source: TIME: Health - October 25, 2022 Category: Consumer Health News Authors: Matthew Perrone/AP Tags: Uncategorized Sleep wire Source Type: news

New TREMFYA ® (guselkumab) Data Show an Overall Clinical Response Rate of Approximately 80 Percent in a Phase 2b Induction Study of Adults with Moderately to Severely Active Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2b QUASAR Induction Study 1 in adults with moderately to severely active ulcerative colitis (UC) with inadequate responses to previous treatments. The data presented at the 2022 American College of Gastroenterology (ACG) Annual Scientific Meeting show an overall clinical response rate of approximately 80 percent in patients who were randomized to TREMFYA® (guselkumab).Clinical responsea at weeks 12 or 24 of the study was ultimately achieved by 80.2 percent of patients who w...
Source: Johnson and Johnson - October 24, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

Colored and Decorative Contact Lenses: A Prescription Is A Must
Decorative contact lenses, also called colored or costume contact lenses, are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the FDA, and you need a prescription to avoid eye injury. Before buying these lenses, here's what to know. (Source: FDA Consumer Health Information Updates)
Source: FDA Consumer Health Information Updates - October 21, 2022 Category: Consumer Health News Authors: FDA Source Type: news