Medical device certification relies on a higher level of documentation than … [Read More...] about Complimentary whitepaper: “5 Essential Steps for Medical Device Certification”
Main Content
Today on MassDevice
- Abbott imaging catheter recall flagged as Class I by FDA
- Will Johnson & Johnson buy Boston Scientific?
- Needham & Co. downgrades Medtronic, Zimmer Biomet shares
- DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes
- Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company
- Zimmer Biomet adds ESG and CEO visibility to executive’s duties
- U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health
White Papers

See why the Q-Sub Program is key to regulatory strategy
| By Nicole Johnson
The Q-Sub Program gives you pre-submission feedback straight from the FDA. … [Read More...] about See why the Q-Sub Program is key to regulatory strategy
Sponsored Content

Hobson & Motzer: Investing in the Future
| By Sponsored Content
An Early Adopter Innovation is in Connecticut-based Hobson & Motzer’s DNA. Throughout the precision metal manufacturer’s 110-year history, the ability to respond to changing demands and market conditions, and to leverage evolving technologies has set it apart in the manufacturing world. “We were early adopters of jig boring, visual grinding, EDM, and wire” says company […]

You’ve Got Data. Is It Helping or Hurting?
| By Sponsored Content
By Bob Steller, Industry Principal – Life Sciences Opportunity could be staring you in the face, but you might not recognize it. As a Life Sciences company, you have so much data. Are you making the best use of it? I was recently talking to a customer who has 90 reports, but most of the information […]

Cordis high resolution electronic proportional pressure controls
| By Sponsored Content
Precise, linear pressure control within a closed-loop system with ultra-high resolution and repeatability The Clippard Cordis is a revolutionary microcontroller primed for escape velocity from a proportional control market that has grown stagnant. Built with the highest quality Clippard proportional valves at its heart, the Cordis is designed to outperform the competition in every way. With […]

Additive Manufacturing Makes Complex, First-in-Industry Medical Devices Possible
| By Sponsored Content
Many innovative, next-generation medical devices and components can only be made with additive manufacturing By Tyler Stark, Senior Director of Additive Manufacturing and Innovation, Spectrum Plastics Group Additive manufacturing (AM), also known as 3D printing, comprises an innovative suite of advanced technologies that enable the fabrication of a variety of components and products, with remarkably […]
Legal News
iRhythm stays silent on federal grand jury subpoenas
More than one year after receiving the first of two federal grand jury subpoenas seeking information … [Read More...] about iRhythm stays silent on federal grand jury subpoenas
Medtronic must sell Intersect ENT subsidiary to satisfy FTC concerns
The Federal Trade Commission has issued a proposed order to require Medtronic (NYSE:MDT) to sell a … [Read More...] about Medtronic must sell Intersect ENT subsidiary to satisfy FTC concerns
DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to … [Read More...] about DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
California appeals court orders Johnson & Johnson to pay $302M in pelvic mesh case
A California appeals court mostly agreed that Johnson & Johnson must pay the state hundreds of … [Read More...] about California appeals court orders Johnson & Johnson to pay $302M in pelvic mesh case
Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case
A Federal Circuit court ruled that Abbott (NYSE:ABT) must face patent infringement claims going back … [Read More...] about Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case
Surgeon wins $20M verdict against J&J’s DePuy Synthes
A federal jury hit DePuy Synthes with a $20 million verdict payable to a surgeon who said the … [Read More...] about Surgeon wins $20M verdict against J&J’s DePuy Synthes
Fujifilm Sonosite files patent infringement lawsuit against Butterfly Network over handheld ultrasound
Fujifilm Sonosite announced today that it filed a patent infringement lawsuit against Butterfly … [Read More...] about Fujifilm Sonosite files patent infringement lawsuit against Butterfly Network over handheld ultrasound
In case you missed it
- Purdue Pharma, Sacklers reach a new $6B opioid settlement deal
- Siemens Healthineers’ Varian faces scrutiny over environmental cleanup at former Massachusetts site
- Baxter settles with the SEC for $18M
- Experiments by Elon Musk’s Neuralink and UC Davis allegedly caused extreme suffering in monkeys
- Align Technology settles patent infringement, antitrust suits with 3Shape
Mergers & Acquisitions.

Will Johnson & Johnson buy Boston Scientific?
Needham & Co. analyst Mike Matson today upgraded his rating of Boston Scientific (NYSE:BSX) shares to Buy, partly because he thinks it’s an acquisition target for Johnson & Johnson (NYSE:JNJ). Said Matson: “If JNJ decides to acquire a large medtech company, we believe that BSX could be a good fit.” BSX shares were up more […]

Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company
Quidel (Nasdaq:QDEL) announced today that it completed its $6 billion acquisition of Ortho Clinical Diagnostics (Nasdaq:OCDX). In December 2021, San Diego-based Quidel and Ortho Clinical Diagnostics came to an agreement under which the former would acquire the latter for $24.68 per share of common stock, using a combination of cash and newly issued shares in […]

Medtronic, DaVita to form new kidney care company
Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) today announced the intent to form a new medical device company for kidney care. The new, independent company — dubbed “NewCo” for now — aims to enhance the patient treatment experience and improve overall outcomes for kidney care patients. According to a news release, the new company will bring together […]

Device developer SeaStar Medical hires chief medical officer
SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in the […]

Report: Dexcom in talks to acquire Insulet
Major players in the diabetes space could join forces as Dexcom (Nasdaq:DXCM) is reportedly in discussions to acquire Insulet (Nasdaq:PODD). Bloomberg reported today that people “with knowledge of the matter” have said talks are ongoing over a potential acquisition and even said an agreement could be reached “in the coming weeks.” Bloomberg’s sources preferred to remain anonymous […]

Alcon to pay $60M to acquire Kala Pharmaceuticals’ dry eye treatment
Alcon (NYSE:ACL) announced today that it agreed to acquire Eysuvis pharmaceutical eye drops from Kala Pharmaceuticals. Geneva, Switzerland-based Alcon will pay $60 million upfront to Kala for the dry eye treatment. As part of the agreement, the company will also acquire Kala’s Inveltys corticosteroid for twice-per-day treatment of post-operative inflammation and pain following ocular surgery. Get the […]

Medtronic completes Intersect ENT acquisition
Medtronic (NYSE:MDT) announced that it completed its previously announced $1.1 billion acquisition of Intersect ENT (Nasdaq:XENT). Fridley, Minnesota-based Medtronic announced in August 2021 that it would acquire all outstanding shares of the Menlo Park, California-based sinus implant maker for $28.25 per share in an all-cash transaction. As a result of the transaction, Medtronic acquires Intersect […]