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BioWorld - Sunday, May 18, 2025
Home » Topics » U.S., BioWorld MedTech

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Cardiovascular.png

Cardiologists pushing back on rule to judge appropriateness of stenting

Jan. 16, 2020
By Mark McCarty
Device makers only can watch when cardiologists grapple with federal agency officials over device utilization. However, cardiologists are punching back hard against a rule used to judge whether a coronary artery stent is appropriately used, thus ensuring these devices won’t suffer a significant drop in utilization.
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DNA data illustration
J.P. Morgan Healthcare Conference

Population genetic studies set up for success, as they aim for health care and research results

Jan. 15, 2020
By Stacy Lawrence
SAN FRANCISCO – Major genetic research efforts designed to encompass millions of people globally have been setting up their infrastructure in recent years to serve both researchers and patients. This work is being done by major national initiatives, such as All of Us in the U.S. and Genomics England in the U.K., as well as by health care systems such as Intermountain and Kaiser.
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Cancer cell and DNA
J.P. Morgan Healthcare Conference

Guardant embraces biopharma research, screening to maintain momentum

Jan. 15, 2020
By Stacy Lawrence
SAN FRANCISCO – Guardant Health Inc. has set the standard for liquid biopsy. That success has catapulted the Redwood City, Calif.-based company from an IPO in the fall of 2018 to a current valuation in excess of $7 billion. It has made its name – and much of its revenue – with its Guardant360 test, a molecular diagnostic test that assesses 74 cancer-related genes from the circulating tumor DNA to aid in designing the best treatment for advanced cancer patients with solid tumors.
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Gavel and scales

Supreme Court passes on Athena patent case despite Solicitor General’s endorsement

Jan. 14, 2020
By Mark McCarty
The U.S. Supreme Court has declined to hear the case of Athena v. Mayo, which many hoped would ease the patent subject matter eligibility problem. This outcome leaves Congress and the Court of Appeals for the Federal Circuit as the only likely sources of resolution for the problem, but there is skepticism as to whether either of these parties is both willing and able to overcome the impasse.
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Globe in DNA helix
J.P. Morgan Healthcare Conference

Amidst launch, 10x Genomics teases new single cell analytics to debut in the next few years

Jan. 14, 2020
By Stacy Lawrence
SAN FRANCISCO – Single-cell analytics has the potential to replace all sorts of biology laboratory equipment, expects Pleasanton, Calif.-based 10x Genomics Inc.
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Business pipeline illustration
J.P. Morgan Healthcare Conference

Medtronic spotlights pipeline, as Ishrak cedes stage a bit to incoming CEO Martha

Jan. 13, 2020
By Stacy Lawrence
SAN FRANCISCO – This was the final presentation for Omar Ishrak at the J.P. Morgan (JPM) Healthcare Conference. He has held the CEO position at Medtronic plc since June 2011. During that period, the Dublin-based company managed to roughly quadruple its valuation to $160 billion from $40 billion – making Ishrak’s tenure clearly a successful one.
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J.P. Morgan Healthcare Conference

Dexcom dips despite upbeat focus on moving into the masses with T2, pregnancy, hospital

Jan. 13, 2020
By Stacy Lawrence
SAN FRANCISCO – Dexcom Inc. is working hard to take its business to the next level. Wall Street has been rewarding it heavily, doubling its market cap to about $21 billion since the end of 2018. But investors pulled back a tad on the company’s presentation at the J.P. Morgan (JPM) Healthcare Conference in San Francisco, sending shares down about 4% despite beating analyst expectations.
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Tau protein in Alzheimer's disease

Tau PET imaging offers the potential to predict the progress of Alzheimer’s disease

Jan. 7, 2020
By Stacy Lawrence
Amyloid and tau proteins are both involved in the disease pathology of Alzheimer’s disease. The diagnostic and treatment research focus has long been on amyloid, which has proven almost entirely fruitless after decades of effort. But tau is becoming better understood, as investigational tau imaging agents offer the ability to visualize its presence in the brain.
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Attorneys say final rules for Stark, AKS drafts unlikely to emerge this year

Jan. 6, 2020
By Mark McCarty
The draft rules for the Stark and Anti-Kickback statutes (AKS) seem to have excluded makers of devices, but Meena Datta of Sidley Austin told BioWorld MedTech that while these agencies have plenty of reasons to rethink that notion, the final rules are unlikely to emerge in 2020 simply because of the complexity of the undertaking. While the final rules may reverse the drafts’ exclusion of makers of devices and diagnostics, device makers were upbeat at the prospect that they could engage in value-based payment arrangements with providers.
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Meta-analysis lends little support to paclitaxel mortality theory

Jan. 2, 2020
By Mark McCarty
The controversy over paclitaxel (PCT)-associated mortality in devices for the peripheral arteries is far from over, but another medical journal article has punched a hole in the credibility of the paclitaxel theory with the conclusion that the evidence is unequivocal and may be unpersuasive to physicians.
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