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Medtech Insight
Number of Followers: 4  Subscription journalISSN (Print) 1876-8008 Published by Informa plc  [10 journals]
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- COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t
Need Premarket Notification- Abstract: The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic...
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Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
FDA Approves Medtronic’s Abre Venous Stent
PubDate: Wed, 28 Oct 2020 16:58:41 GMT
- Abstract: The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic...
- Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With
Ultrasound- Abstract: A trial in Italy sponsored by Butterfly Network showed the company’s portable ultrasound system can help identify patients with COVID-19... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
FDA Approves Medtronic’s Abre Venous Stent
PubDate: Wed, 28 Oct 2020 14:40:56 GMT
- Abstract: A trial in Italy sponsored by Butterfly Network showed the company’s portable ultrasound system can help identify patients with COVID-19...
- Execs On The Move: Vapotherm Promotes International Sales VP,
SparingVision Chairman Now Also CEO- Abstract: Vapotherm VP of international sales promoted to chief commercial officer; SparingVision chairman also takes on roles as president and CEO;... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
FDA Approves Medtronic’s Abre Venous Stent
PubDate: Wed, 28 Oct 2020 14:16:39 GMT
- Abstract: Vapotherm VP of international sales promoted to chief commercial officer; SparingVision chairman also takes on roles as president and CEO;...
- Election 2020: Medtech PAC Funds Go To US House Reps Boosting Trade Deals,
COVID-19 Tests- Abstract: Medtech Insight takes a look at political action committee money that medtech entities have been contributing to US House members... Related Stories
Financing: Q3 Roundup Shows Fall In Device Company Activity But A Rise In IVDs
Device Week, 23. October 2020 – Conference Spotlight TCT, HLTH
Device Week, 23. October 2020 – Conference Spotlight – TCT, HLTH
PubDate: Wed, 28 Oct 2020 14:11:37 GMT
- Abstract: Medtech Insight takes a look at political action committee money that medtech entities have been contributing to US House members...
- FDA Approves Medtronic’s Abre Venous Stent
- Abstract: The approval is based on the results ABRE clinical study, which showed the stent improved patency iliofemoral veins in 88%... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Wed, 28 Oct 2020 10:43:04 GMT
- Abstract: The approval is based on the results ABRE clinical study, which showed the stent improved patency iliofemoral veins in 88%...
- Experts Call For Unifying Measures For EU Political And Regulatory
Oversight- Abstract: Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Wed, 28 Oct 2020 06:25:46 GMT
- Abstract: Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient...
- IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To
Do- Abstract: It’s time to focus on how the diagnostics sector will comply with the EU’s IVD Regulation. TÜV SÜD expert, Andreas... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Wed, 28 Oct 2020 05:59:51 GMT
- Abstract: It’s time to focus on how the diagnostics sector will comply with the EU’s IVD Regulation. TÜV SÜD expert, Andreas...
- Exact Goes All-In On Multi-Cancer Screening With $2.15Bn For Thrive; $410M
For Base Genomics- Abstract: Deals give the company access to technologies to increase the accuracy of multi-cancer blood tests. Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Wed, 28 Oct 2020 05:47:07 GMT
- Abstract: Deals give the company access to technologies to increase the accuracy of multi-cancer blood tests.
- QUOTED. 28 October 2020. Serge Bernasconi.
- Abstract: A new report focused on the European market says that winning trust is the key to taking AI adoption to... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Wed, 28 Oct 2020 00:31:57 GMT
- Abstract: A new report focused on the European market says that winning trust is the key to taking AI adoption to...
- MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work
With What’s There- Abstract: US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate... Related Stories
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Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Tue, 27 Oct 2020 17:58:27 GMT
- Abstract: US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate...
- FDA Bumps PMA Compliance Date For AED Accessories To February 2022
- Abstract: The US agency is giving manufacturers of automated external defibrillator accessories roughly 15 more months to comply with a 2015... Related Stories
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Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Tue, 27 Oct 2020 14:20:52 GMT
- Abstract: The US agency is giving manufacturers of automated external defibrillator accessories roughly 15 more months to comply with a 2015...
- Dealmaking: Q3 Roundup Shows Deal Values Jump From Prior Quarter
- Abstract: Device company M&A values reached $17.9bn in Q3, while in vitro diagnostic firms and research tools players completed M&A activity... Related Stories
Election 2020: Medtech PAC Funds Go To US House Reps Boosting Trade Deals, COVID-19 Tests
Financing: Q3 Roundup Shows Fall In Device Company Activity But A Rise In IVDs
Device Week, 23. October 2020 – Conference Spotlight TCT, HLTH
PubDate: Tue, 27 Oct 2020 14:20:07 GMT
- Abstract: Device company M&A values reached $17.9bn in Q3, while in vitro diagnostic firms and research tools players completed M&A activity...
- EU Framework For Patient Preference Studies Under Review
- Abstract: An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Tue, 27 Oct 2020 12:19:47 GMT
- Abstract: An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice...
- Warning Letter Roundup & Recap – 27 October 2020
- Abstract: No device-related warning letters were released by the US FDA the week of 27 October. Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Tue, 27 Oct 2020 10:32:46 GMT
- Abstract: No device-related warning letters were released by the US FDA the week of 27 October.
- €200Bn And 400K Lives Saved Each Year' Deloitte Quantifies Value Of
AI In European Health Care- Abstract: While personal data security must be balanced againt the right to health, winning “trust” is the key to taking AI... Related Stories
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Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Tue, 27 Oct 2020 05:32:08 GMT
- Abstract: While personal data security must be balanced againt the right to health, winning “trust” is the key to taking AI...
- QUOTED. 27 October 2020. Michael Mussallem.
- Abstract: TAVR procedure volumes have returned to or exceeded pre-pandemic levels in most locations, Edwards LifeSciences CEO Michael Mussallem said during... Related Stories
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Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Tue, 27 Oct 2020 00:30:19 GMT
- Abstract: TAVR procedure volumes have returned to or exceeded pre-pandemic levels in most locations, Edwards LifeSciences CEO Michael Mussallem said during...
- Cala Health Receives FDA Breakthrough Designation For Wrist-Worn Tremor
Device- Abstract: Cala Health expects to initiate telemedicine-based clinical trials of Cala Trio in patients with Parkinson’s disease by year-end. Related Stories
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Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Mon, 26 Oct 2020 20:06:15 GMT
- Abstract: Cala Health expects to initiate telemedicine-based clinical trials of Cala Trio in patients with Parkinson’s disease by year-end.
- COVID-19 Antigen Template: FDA Adds Info On Asymptomatics Studies,
Multiplex Tests- Abstract: The US agency on 26 October updated its emergency use authorization template to include a somewhat lengthy section on recommendations... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Mon, 26 Oct 2020 16:26:14 GMT
- Abstract: The US agency on 26 October updated its emergency use authorization template to include a somewhat lengthy section on recommendations...
- Latest Commission Charts Show How Pandemic Is Stalling New Notified Body
Appointments- Abstract: Despite the urgency to have many more notified bodies designated under the MDR and IVDR, COVID-19 fall-out has resulted in... Related Stories
COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification
Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound
Execs On The Move: Vapotherm Promotes International Sales VP, SparingVision Chairman Now Also CEO
PubDate: Mon, 26 Oct 2020 08:16:42 GMT
- Abstract: Despite the urgency to have many more notified bodies designated under the MDR and IVDR, COVID-19 fall-out has resulted in...
- Financing: Q3 Roundup Shows Fall In Device Company Activity But A Rise In
IVDs- Abstract: During the third quarter, device company fundraising totaled $3.3bn; while in vitro diagnostic firms and research tools players raised $3.4bn. Related Stories
Election 2020: Medtech PAC Funds Go To US House Reps Boosting Trade Deals, COVID-19 Tests
Device Week, 23. October 2020 – Conference Spotlight TCT, HLTH
Device Week, 23. October 2020 – Conference Spotlight – TCT, HLTH
PubDate: Mon, 26 Oct 2020 07:44:33 GMT
- Abstract: During the third quarter, device company fundraising totaled $3.3bn; while in vitro diagnostic firms and research tools players raised $3.4bn.
