Deep Dive: Page 3
Industry insights from our journalists
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5 things medtech can expect from FDA in 2021
"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.
Greg Slabodkin • March 15, 2021 -
Hospitals lift curtain on prices, revealing giant swings for hips, knees and more
At a Sutter hospital in San Francisco, a joint replacement ranges from $22,865 to $101,571, accordind to a Healthcare Dive analysis of data hospitals are required to report as of January.
Samantha Liss and Nami Sumida • March 11, 2021 -
Brian Tucker / BioPharma Dive
4 healthcare antitrust issues to watch
The FTC is looking to get more aggressive with anticompetitive tie-ups while states eye ways to beef up oversight. And if handed the reins of HHS, Xavier Becerra would likely put an antitrust lens to potential rules.
Samantha Liss • March 4, 2021 -
Fotolia
3 big predictions for digital health in 2021
As tech and data sharing become more pervasive, healthcare will likely pivot to being more predictive and telehealth will evolve, giving rise to new modalities of care. This will force companies to invest more in cybersecurity.
Rebecca Pifer • Jan. 29, 2021 -
CGM, insulin pump players look to 2021 as watershed year for diabetes wearables market
Insulet, Dexcom and Medtronic have product launches set for this year, and all look to capitalize on the recent skyrocketing of virtual care due to the coronavirus pandemic.
Ricky Zipp • Jan. 29, 2021 -
Abbott, Edwards focus on mitral valve as market projected to rival TAVR
Companies have zeroed in on TAVR in recent years, but in 2021 and beyond, experts and industry are looking to the mitral market for the next big structural heart splash.
Ricky Zipp • Jan. 25, 2021 -
MDR-IVDR bottleneck persists as EU launches 1st Eudamed module
"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," an official at Ireland's National Standards Authority said.
Nicholas Wallace • Dec. 14, 2020 -
Boston Scientific's Lotus ditch creates 'duopoly' in growing TAVR market
Edwards Lifesciences and Medtronic are now the primary rivals in the transcatheter aortic valve replacement market, which analysts expect to rapidly grow in coming years.
Ricky Zipp • Dec. 8, 2020 -
Adeline Kon/MedTech Dive
5 ways COVID-19 is reshaping the medtech industry
Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.
Maria Rachal and Greg Slabodkin • Oct. 1, 2020 -
Photo by Getty; photo illustration by Michelle Rock / Medtech Dive
Coronavirus testing hits a wall: Where do we go from here?
As LabCorp and Quest are backlogged in delivering molecular test results, some public health officials are calling for a shift in testing approach from slow and accurate to fast and good enough to meet demand.
Greg Slabodkin • July 27, 2020 -
Photo by Getty; photo illustration by Michelle Rock / Medtech Dive
Medtechs reboot with patients, providers after elective surgeries bottom out
Recovery of procedures critical to device companies came quicker than many in the industry expected. Now, device makers are adapting as business volumes normalize and COVID-19 continues to spread.
Maria Rachal • July 27, 2020 -
No silver bullet: LabCorp and Quest hawk return-to-work COVID-19 tests but employers not rushing in
One employer group official noted "hype" around antibody testing with inconclusive evidence about the immunity of individuals who test positive for the antibodies.
Greg Slabodkin • June 22, 2020 -
Getty Images
How tariffs ravaged the COVID-19 medical supply chain
Months into the pandemic, the U.S. faces an ongoing shortage of PPE, with some of those products still subject to tariffs.
Deborah Abrams Kaplan • May 29, 2020 -
Kendall Davis/MedTech Dive
Telehealth is having a moment. What does its future look like after COVID-19?
Employers should expect workers to embrace telehealth post pandemic, sources told HR Dive, even if concerns about billing and security persist.
Ryan Golden • May 7, 2020 -
Brian Tucker/MedTech Dive
Sunlight doesn't dent industry funding to doctors over half-decade
While many manufacturers tell MedTech Dive boosted spending can be attributed to M&A, watchdogs say the payments can sometimes represent a conflict of interest for doctors.
Maria Rachal and David Lim • Dec. 12, 2019 -
Dexcom app outage highlights communication pitfalls for device makers
"This isn't the main course of what Dexcom offers. It's a side dish," said one parent of a child with Type 1 diabetes. "A good portion of our community has looked at it as a main course."
Maria Rachal • Dec. 10, 2019 -
Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure'
FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency and override state legislation to get sterilization plants back online, one advisory panel member said.
David Lim • Nov. 8, 2019 -
Retail makes its case, telehealth and voice tech dominate: 6 takeaways from HLTH19
Consumerism has its limits, interoperability rules face execution challenges and more from Las Vegas.
Rebecca Pifer • Nov. 6, 2019 -
Getty Images
Deal wave expected as private equity eyes orthopaedic practices
The business of replacing hips and knees is a lucrative area for investors as joint replacements are set to rise and care migrates to outpatient settings.
Samantha Liss • Oct. 25, 2019 -
Pharmacogenetic test makers cheer UnitedHealth coverage. Other payers aren't there yet.
"I've been concerned that the hype around pharmacogenetics, at least for depression, has gotten out ahead of the data," James Potash, director of psychiatry at the Johns Hopkins University, said.
Graison Dangor • Aug. 27, 2019 -
Brian Tucker
Looming EPA ethylene oxide rules hang over device supply chain
The medical device industry is lobbying Capitol Hill and statehouses, warning limited access to the sterilant could pose deadly disruptions.
David Lim • June 25, 2019 -
Kendall Davis / BioPharma Dive
Inside Quest Diagnostics, LabCorp's supply chain breach
The intrusion happened inside the American Medical Collection Agency, but responsibility is shared through its partner ecosystem.
Samantha Schwartz • June 6, 2019 -
Yujin Kim / BioPharma Dive
Will a big needle burst the NASH bubble?
With less invasive tests still a few years off, doctors worry liver biopsies will limit access to the initial wave of NASH drugs — if any make it to market.
Jacob Bell • May 14, 2019 -
Danielle Ternes
CDRH Director Shuren: Safety and innovation are 'two sides of same coin'
The device chief said in a wide-ranging interview with MedTech Dive a major challenge for the agency is fighting the perception that speeding new devices to market comes at the cost of patient safety, or vice versa.
David Lim • April 15, 2019 -
How AI and machine learning are changing prosthetics
"Our bodies natively have control loops at various levels, and that's really where AI comes into play" in creating next-generation prostheses, said Robert Armiger of Johns Hopkins' Advanced Physics Lab.
Meg Bryant • March 29, 2019
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