Category: Medical

November 17, 2023

Section 506J of the Federal Food, Drug, and Cosmetic Act requires manufacturers of certain devices to tell the FDA in advance if they are permanently ending production of the product or face an interruption that is likely to meaningfully impact […]

November 10, 2023

Acutus developed mapping technology to try to reduce the rate of atrial fibrillation recurrence after patients undergo ablation. The company pitched its non-contact approach to mapping as a better fit for atrial fibrillation and other complex or unstable arrhythmias, but […]

November 2, 2023

The guidance, first issued in May 2020, was supposed to expire at the end of the public health emergency. The policy allowed for any required production process changes, like social distancing, or manufacturing changes due to supply chain shortages, which […]

October 10, 2023

Innovation drives growth in the biotech and pharmaceutical space. According to The Pharmaceutical Research and Manufacturers of America (PhRMA), the U.S. biopharmaceutical sector directly supports more than 900,000 jobs across the economy. Manufacturing employs more than 330,000 high-wage workers in […]

September 1, 2023

Beta Bionics raised a $57 million series C financing round early last year. That financing, which was co-led by a syndicate of venture capital funds with an assist from strategic partner Novo Nordisk, equipped the company to develop iLet, file […]

August 9, 2023

Musk has made big claims since founding Neuralink in 2016, pitching its technology as both a treatment of conditions such as blindness, and a way to augment humans to compete against artificial intelligence. To start testing if those claims hold […]

July 27, 2023

Teva Pharmaceutical Industries Ltd., a leading generic pharmaceutical company, (NYSE and TASE: TEVA) announced today that it is working with Honeywell (NASDAQ: HON) to help reduce energy consumption and carbon emissions at its Debrecen, Hungary, manufacturing facility. Teva will leverage […]

July 20, 2023

Johnson & Johnson raised its full-year earnings forecast for the second quarter in a row, reflecting improved procedure volumes and a steady drumbeat of new product launches in its medtech segment. The New Brunswick, New Jersey-based company now expects revenue […]

July 17, 2023

In a groundbreaking move to revolutionize the field of biomedical research, Alfa Chemistry recently announced the launch of its highly anticipated custom design and manufacturing services for organs-on-chips. This cutting-edge technology provides scientists and researchers with an innovative platform to […]

June 15, 2023

Enzene Biosciences, Ltd., a global biotech company based in Pune, India, will invest $50 million to open a state-of-the-art biopharmaceutical manufacturing plant in New Jersey. Operations in the new facility, located on the Princeton West Innovation Campus in Hopewell, are […]

June 1, 2023

FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed […]

May 24, 2023

Integra initiated the voluntary recall after an internal investigation found endotoxin testing deviations. The deviations may have resulted in the release of medical devices with levels of endotoxins that exceed the levels permitted by the product specifications, the company said. […]

May 2, 2023

In the multibillion-dollar market for diabetes technology, Medtronic’s U.S. diabetes sales have declined in the last four years as the company grappled with regulators and competitors rolled out new devices. With two strokes of a pen in late April, the […]

April 26, 2023

Boston Scientific reported first-quarter sales that exceeded the company’s forecast, saying it gained market share across its businesses as demand for procedures using its medical devices rebounded from a year ago. The company raised its full-year sales and profit forecasts, […]

April 11, 2023

Medical device trade groups raised concerns about the capacity to sterilize medical devices in response to proposed ethylene oxide regulations by the Environmental Protection Agency. The EPA seeks to reduce emissions of the gas, which it says can cause cancer […]

March 13, 2023

Pfizer Inc. has agreed to pay $43 billion for biotech Seagen Inc. SGEN 16.29%increase; green up pointing triangle and its pioneering class of targeted cancer drugs. Under the terms, Pfizer would pay $229 a share in cash, the drugmaker said […]

February 14, 2023

J&J’s case expanded from claiming Alcon infringed patents to accusing the company of stealing electronic copies of the source code for its own iFS Laser eye surgery device. According to J&J, Alcon “incorporated at least 26,000 lines of that code […]

February 2, 2023

Eli Lilly & Co. said revenue for the recently ended quarter fell 9% as lower sales of its Covid-19 antibodies and the strong U.S. dollar weighed on growth. The pharmaceutical company said Thursday that quarterly revenue fell 9% to $7.30 […]

January 26, 2023

As medical device companies strive to remain competitive and agile in today’s fast-paced world, they must center manufacturing in business optimization plans while embracing a design-to-value approach from the start. The COVID-19 pandemic accelerated the healthcare industry’s transformation, driving faster […]

January 10, 2023

Prealize, an artificial intelligence (AI)-enabled predictive analytics company, today announced the release of its much anticipated, third annual State of Health Report. Prealize’s 2023 State of Health – In The Aftermath identifies the top at-risk conditions and utilization spikes that […]