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Former Theranos lab director faces cross-examination, says he was source for Wall Street Journal uncoverings

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021.[Photo by David Paul Morris/Bloomberg via Getty Images]

Former Theranos lab director Adam Rosendorff took the stand for a second day at the Elizabeth Holmes federal fraud trial to face cross-examination from the defense.

The lab director testified that he felt pressured by management to defend lab tests despite the inaccuracies, multiple media sources report. For example, in several email exchanges with Holmes’ brother Christian Holmes, Rosendorff was asked to come up with “constructive” ways of dealing with a doctor who was questioning the results of a cholesterol test performed by one of Theranos’ machines.

Rosendorff said that he told Christian Holmes that, “if you are asking me to defend these values, then the answer is no,” NBC Bay Area reports. Rosendorff also said in the email exchange that…

Former Theranos lab director faces cross-examination, says he was source for Wall Street Journal uncoverings

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021. [Photo by David Paul Morris/Bloomberg via Getty Images]Former Theranos lab director Adam Rosendorff took the stand for a second day at the Elizabeth Holmes federal fraud trial to face cross-examination from the defense.

The lab director testified that he felt pressured by management to defend lab tests despite the inaccuracies, multiple media sources report. In several email exchanges with Holmes’ brother Christian Holmes, Rosendorff was asked to come up with “constructive” ways of dealing with a doctor who was questioning the results of a cholesterol test performed by one of Theranos’ machines.

Rosendorff said that he told Christian Holmes that, “if you are asking me to defend these values then the answer is no,” NBC Bay Area reports. Rosendorff also said in the email exchange that he thought the most “constructiv…

FDA clears Caretaker Medical’s next-gen noninvasive blood pressure monitoring platform

Caretaker Medical’s VitalStream [Image courtesy of VitalStream]Caretaker Medical (Charlottesville, Virginia) has secured FDA clearance for its next-generation VitalStream wireless blood pressure and hemodynamic monitoring platform, the company said today.

The VitalStream wireless platform expands on the previously cleared Caretaker4 wireless patient monitor. The platform, according to the company, can measure blood pressure and hemodynamic parameters with every heartbeat. The result is an uninterrupted stream of real-time data that eliminates “blind spots” between manual spot-check measurements.

The VitalStream platform relies on a low-pressure finger sensor. Caretaker Medical is marketing it as a non-invasive alternative to A-lines and arterial catheters, enabling ICU-grade patient monitoring at all points of care.

“Accurate, non-invasive hemodynamic monitoring is certainly preferred to invasive A-lines in most patient populations. My use…

Boston Scientific to invest more than $30M in Irish facility

[Image courtesy of Google Maps]Boston Scientific (NYSE:BSX) will invest €30 million (about $34 million) in its Cork, Ireland facility, the Irish government announced today.

The Irish government supported the research, development and innovation (RD&I) investment through IDA Ireland. The money will go toward accelerating the development and manufacturing of minimally-invasive medical technologies that treat patients suffering from cancer and peripheral arterial diseases worldwide.

Boston Scientific will create 70 new engineering and production jobs in Cork over the next three years — on top of the 1,200 people employed at the site.

“This investment will allow the company to grow and develop its world-leading technologies and ensure that it continues helping to improve and save lives. Ireland is globally recognized as a center of excellence for the Life Sciences, and this investment is a real vote of confidence in us and our capacity,” said Le…

LumiraDx goes public as SPAC deal closes

The LumiraDx platform and test strip [Image courtesy of LumiraDx]LumiraDx shares are trading at more than $8 apiece on the Nasdaq today under the symbol LMDX after the company completed its merger with a SPAC called CA Healthcare Acquisition Corp.

The point of care diagnostic testing company has a pipeline of more than 30 assays across common health conditions, including infectious diseases, cardiovascular diseases, diabetes and coagulation disorders. The LumiraDx has already found use globally, including CVS Pharmacy in the U.S. and the National Health Service and Boots in the U.K.

“LumiraDx was founded to disrupt current point of care diagnostic options by providing rapid and highly accurate results wherever the patient is,” LumiraDx CEO Ron Zwanziger said in a news release yesterday.

“Our testing technology, which allows us to rapidly scale and offer lab-comparable testing with fast results across health conditions, is impacting healthcare across market …

FDA approves Abbott’s next-gen Amplatzer Talisman

The Amplatzer Talisman PFO occlusion system [Image courtesy of Abbott]Abbott (NYSE:ABT) announced today that it’s won FDA approval for its Amplatzer Talisman PFO occlusion system for stroke prevention.

In addition, the FDA cleared the Amplatzer Talisman delivery sheath.

The Amplatzer Talisman is a next-generation version of the company’s Amplatzer PFO occluder, originally approved in 2016. The Talisman has an additional 30 mm device size, and it cuts the preparation time because all Talisman PFO occluders come pre-attached to the delivery cable.

About a quarter of adults have a patent foramen ovale (PFO) — in which a flap-like opening inside the heart didn’t close after they were babies. A PFO could cause a stroke if blood clots pass from the right side of the heart to the left, enabling them to travel to the brain.

“Extensive clinical trial data and the latest guidance from industry organizations support PFO closure as an imp…

Ambu secures CE mark for single-use bronchoscope and sampling system

Ambu recently announced that its single-use bronchoscope and specimen sampling system won CE mark approval.

Ambu’s aScope 4 Broncho sampler set is a sterile, single-use device for bronchial wash and bronchoalveolar lavage procedures.

Get the full story on our sister site, Medical Tubing + Extrusion.

Former Boston Scientific executive Evan Brasington joins Perineologic

Corbin Clinical Resources’s Perineologic this week announced that it appointed Evan Brasington as chief commercial officer.

Brasington will be responsible for leading the Cumberland, Maryland-based company’s commercial strategy including operations, marketing, sales and distribution.

“We are very pleased to welcome Evan to the Perineologic team. He brings more than 30 years of leadership experience in the medical device sector, including planning and execution of global marketing and sales strategies to grow marketplace adoption of new technological solutions,” president and founder Matthew Allaway said in a news release. “Our company is dedicated to bringing patients a better, safer and more precise option for prostate biopsy, and Evan’s deep knowledge of the urology market will be invaluable in expanding adoption of the PrecisionPoint system in the years ahead.”

Prior to joining the company, Brasington held num…

FDA approves Transmedics’ OCS Liver preservation system

TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death.

Andover, Massachusetts-based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function to allow for ex-vivo assessment of liver allografts from brain dead and circulatory dead donor livers.

“We are extremely proud of this approval of our OCS Liver technology, as it represents the first and only liver perfusion technology to be approved by the FDA in the United States,” president and CEO Waleed Hassanein said in a news release. “TransMedics is now uniquely positioned to offer its OCS perfusion technology for lung, heart and liver transplantation. Our goal is to leverage these FDA approvals to make more donor organs available to help patients in need of the life-saving transplant procedure. We are looking forward to expanding our…

CDC analysis finds COVID-19 boosters generally elicit mild-to-moderate side effects

Most third doses of mRNA COVID-19 vaccines elicit side effects in line with that of the second dose, according to a CDC report.

The study analyzed immunocompromised recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccine recipients eligible for a third dose.

It pulled data from 22,191 V-safe registrations. V-safe is a CDC-created smartphone-based system for tracking adverse events. Just under one-third (31.8%) of participants reported health impacts, while 28.3% said they could not perform routine daily activities — most often on the day following receipt of the third dose.

Referencing the report at a White House briefing, CDC Director Dr. Rochelle Walensky, concluded “COVID-19 vaccine booster doses so far are well tolerated”

Injection site reactions were slightly more common among the mRNA vaccine recipients than after receiving the second dose. Systemic reactions were somewhat less common post-third dose for both Pfizer-BioNTe…

Lilly wins Erbitux label expansion for colorectal cancer indication

FDA has approved a new indication for Lilly‘s (NYSE:LLY) Erbitux (cetuximab injection) in combination with Pfizer’s Braftovi (encorafenib) to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation confirmed with an FDA-approved test.

The indication covers previously-treated patients.

Erbitux is currently the only FDA-approved antibody that targets the epidermal growth factor receptor (EGFR). Merck (NYSE:MRK) was also involved in developing the drug.

The recent label expansion is based on data from Pfizer’s Phase 3 BEACON CRC study, which focused on patients with metastatic colorectal cancer with a BRAF V600E mutation.

The latest approval gives Erbitux a total of seven indications covering various colorectal and head-and-neck cancers.

“The BEACON study showed that the combination of ERBITUX and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mu…

Lilly cuts price of Lispro insulin by 40%

Starting January 1, 2021, Eli Lilly and Company (NYSE:LLY) will reduce the list price of Insulin Lispro Injection in the U.S. to match 2008 levels. The 40% price cut will also extend to the company’s non-branded insulins.

Still, the company acknowledged that people with fixed insurance co-pays or beneficiaries of Lilly’s affordability programs might not see direct savings for Insulin Lispro Injection.

In recent years, a number of politicians and physicians have complained about the high cost of insulin in the U.S.

For instance, Senator Chuck Grassley (R-Iowa) lamented earlier this year that insulin prices had “gone through the roof.” Several Democratic presidential candidates in 2020 also lambasted the high cost of insulin.

A 2020 article published in Mayo Clinic Proceedings reported that analog insulin costs 10 times more in the U.S. than in other developed nations.

Three companies, Lilly, Novo Nordisk and Sanofi-Aventis, control the bulk …